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Quality Failures

 

Withholding & Withdrawing Due to Quality Defects in Pharmaceuticals - March 2017

No.

Product

Manufacturer / Supplier

Failure / Defect

Decision

01

Hydrocortisone Sodium Succinate for Injection BP 100 mg. (AMCORT)

AMN Lifesciences Pvt. Ltd., 150, Sahajananad Estate, Sarkhej-Tal City, Ahemedabad, Gujarat, India.

Sample does not confirm to BP specifications with respect to particulate contamination.

Withhold the Batch AMN005015.

02

Fusidic Acid BP 1.0% Viscous Eye Drop. (Fusigel)

Elko Organization (Pvt) Ltd., Plot No. 27 & 28, Sector 12-B, North Karachi Industrial Area, Karachi, Pakistan.

Sample is unsatisfactory due to discrepancies observed  in the containers of different batches.

Withhold the batch EBB-43

03

Paracetamol Tablets BP 500 mg.

M.S.J. Industries (Ceylon) (Private) Ltd, 126, Aluth Mawatha Road, Colombo 15, Sri Lanka.

Sample does not confirm BP specification for the test for microbial contamination. Discoloration was observed  on the surface of the tablets in intact packs.

Withdraw the Product

Withholding & Withdrawing Due to Quality Defects in Pharmaceuticals - February 2017

No.

Product

Manufacturer / Supplier

Failure / Defect

Decision

01

Co-Trimoxazole Oral Suspension BP 240 mg /5 ml. (L-Trim) 50 ml Bottles.

Leben Laboratories Pvt. Ltd,

Off: 11, Mahavir Mansion, 70 Trinity Street, Mumbai - 400 002, India.

Works: L-4 Phase-111, M.I.D.C. Akola 444104 (Maharashtra),India

Sample dose not confirm to BP specifications with respect to acidity.

Withhold the Batch L-3613.

02

Domperidone Oral Suspension BP 5 mg / 5 ml. 60 ml Bottles

Interpharm (Pvt) Ltd., Madapatha Road, Piliyandala, Sri Lanka.

Sample is unsatisfactory due to presences of dead insects in the intact solution.

Withdraw the Batch 57M603.

03

Paracetamol Tablets BP 500 mg. - 1000 Tablets / Pack.

M.S.J. Industries (Ceylon) (Private) Ltd, 126, Aluth Mawatha Road, Colombo 15, Sri Lanka.

Sample does not confirm to BP specifications for the test for microbial contamination.

Withdraw the Batch 1663026.

04

Ceftriaxone for Injection USP 1000 mg (SOLOCEF 1000mg)

Yeluri Formulations Pvt. Ltd, Sy. No. 296/7/6, I. D. A., Bollaram,  Medak District - 502 325, Telangana, India.

Sample does not confirm to USP specifications with respect to uniformity of dosage units.

Withdraw the Batch YS05102

Withholding & Withdrawing Due to Quality Defects in Pharmaceuticals - January 2017

No.

Product

Manufacturer / Supplier

Failure / Defect

Decision

01

Ceftriaxone for Injection USP 1 g (NEFZON)

Nitin Lifesciences Ltd. 92-93, Sector-3, H.S.I.D.C., Industrial Area, Karnal-132001, Haryana, India.

Sample does not conform to USP specifications with respect to Constituted Solution.

Withdraw the Batch NPE-552

02

Amoxicillin Oral Suspension B.P. 125 mg / 5 ml (AMOXYWN)

BELCO Pharma, 515, M.I.E., Bahadurgarh-24507, (Haryana), India.

Sample is unsatisfactory with respect to the manufacturer’s specifications.

Withdraw the Batch D-171A3

03

Ferrous Sulphate Tablets BP 200 mg

Bajaj Healthcare Ltd., Formulation Division, R.S. No. 1818, Manjusar-Savi Road, At & Post: Manjusar, Tal-Savli, Dist: Vadodara-391775, India.

Samples are considered unsatisfactory due to capping and breaking of tablets in intact blister packs.

Withhold the Batches 0241403, 0241601

Withholding & Withdrawing Due to Quality Defects in Pharmaceuticals - December 2016

No.

Product

Manufacturer / Supplier

Failure / Defect

Decision

01

Clomifene Tablets BP 50 mg (Gynofen)

Zafa Pharmaceutical Laboratories (Pvt) Ltd, A-46, S.I.T.E., North Karachi, Karachi, Pakistan.

Sample is considered unsatisfactory as the tablets break into tiny pieces when taking out from the blister pack.

Withdraw the Batch 12.

02

Paracetamol Tablets BP 500 mg

Themis Pharmaceuticals, Chemosyn Limited. 69-B, G.I.D.C. Industrial Estate,VAPI-396195, India for Stallion Laboratories Pvt. Ltd. Gujarat, India.

Sample does not confirm to BP specification with respect to test for Uniformity of weight.

Withdraw the Batch VEP-59.

03

Multivitamin Drops 15 ml Bottle         (Becadex Drops)

Glaxo Wellcome Ceylon Limited, 121, Galle Road, Kaldemulla, Moratuwa, Sri Lanka.

Sample is unsatisfactory due to leakage from intact bottles.

Withdraw the Batch 16F2

04

Cefuroxime for injection USP 250 mg (Zafurox)

Zafa Pharmaceutical Laboratories (Pvt) Ltd, A-46, S.I.T.E., North Karachi, Karachi, Pakistan.

Sample is considered unsatisfactory due to presence of a piece of glass inside a reconstituted vial.

Withdraw the Batch 16

Withholding & Withdrawing Due to Quality Defects in Pharmaceuticals - November 2016

No.

Product

Manufacturer

Reason

Decision

01

Albendazole Tablets 400 mg (ENDWORM)

Bafna Pharmaceuticals Ltd, No. 147, Madhavaram Redhills High Road, Grantlyon Village, Chennai 600052, India.

Sample is considered unsatisfactory as the tablets break when taking out from the blister packs.

Withhold the batch TE 3907.

02

Cefuroxime Axetil for Oral Susooension USP 125 mg / 5 ml (MILCEF-125) - 70 ml Bottles.

The Madras Pharmaceuticals, 137-B, Old Mahabalipuram Road, Karapakkam, Chennai, India.

Sample is unsatisfactory due to colour variation of the powder and reconstituted solution, among samples of the same batch.

Withhold the batch M14A094.

Withholding Due to Severe Adverse Reactions in Pharmaceuticals - November 2016

No.

Product

Manufacturer

Adverse Reactions Reported

Decision

01

Iohexol USP 350 mg I / ml (X-ray contrast Media)

GE Healthcare, Ireland.

Four deaths were reported due to severe allergic reactions.

Withhold the batch 13435509.

Withholding & Withdrawing Due to Quality Defects in Pharmaceuticals - October 2016

No.

Product

Manufacturer

Reason

Decision

01

Meropenem for Injection USP 500 mg (MERONASH 500)

Shamshree Lifesciences Ltd, Plot No. 11, Industrial Area, Katha Bhatoli Kalan, Baddi 173205, (H.P.), India.

Sample is considered unsatisfactory due to presence of a piece of glass inside a reconstituted vial.

Withdraw the batch P003602.

02

Ceftriaxone for Injection USP 1000 mg (SOLOCEF 1000)

Yeluri Formulations Pvt. Ltd, Sy. No. 296/7/6, IDA, Bollaram, Medak District-502325, Telangana, India.

Sample does not confirm to USP specifications with respect to constituted solution.

Withdraw the batch VS05120.

03

Thiamine Injection BP 100 mg / 2 ml (SOLOCEF 1000)

Sterile-Gene Lifesciences (Pvt) Ltd, No. 45, Mangalam Village, Villianur Commune, Puducherry-605110, India.

Sample does not confirm to BP specification with respect to assay.

Withhold the batch SPH15C001.

04

Gastro-Resistant Sodium Valproate Tablets BP 200 mg.

AMN Lifesciences Pvt. Ltd, 150, Sahajanand Estate, Sharkhej, Tal. City: Ahmedabad, GUjarat State, India.

Sample is considered unsatisfactory as some tablets are melted in metal strips.

Discontinue to use tha packs Which show tha defect.

Batches: S-11008, S-11016 S-11017.

Withholding Due to Severe Adverse Reactions in Pharmaceuticals - October 2016

No.

Product

Manufacturer

Adverse Reactions Reported

Decision

01

Benzathine Penicillin (Sterile) G Benzathine 900 mg USP (1.2 MIU)

Karnataka Antibiotics & Pharmaceuticals Limited, India.

Two deaths were reported due to severe allergic reactions.

Withhold the batch 1100815.

Withholding & Withdrawing Due to Quality Defects in Pharmaceuticals - September 2016

No.

Product

Manufacturer

Reason

Decision

01

Erythromycin Ethyl Succinate for Oral Suspension USP 125 mg / 5 ml - 100 ml.

Ratnamani Healthcare Pvt. Ltd., Survey No: 750/1, Ahmedabad- Mehsana Highway, Vill: Indrad, Tal: Kadi, Dist: Mehsana, Gujarat, India.

Sample is considered unsatisfactory due to seperation of the suspension into two layers immediately after reconstitution and the lower layer appears to be clearer than the upper layer which is with granular contents.

Withdraw the batch APE 002. (08/09/2016)

02

Fucidic Acid BP 1.0% Viscous Eye Drops  (FUCIGEL)

Elko Organization (Pvt) Ltd, Plot No. 27 & 28, Sector 12-B, North Karachi Industrial Area, Karachi, Pakistan.

Sample is considered unsatisfactory as screw caps of the containers were broken affecting the container integrity and the sterility of the contents.

Withhold the batch EBB-24 (22/09/2016)

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - August 2016

No.

Product

Manufacturer

Reason

Decision

01

Cefuroxime Axetil for Oral Suspension USP 125 mg / 5 ml (MILCEF-125) - 70 ml Bottles

The Madras Pharmaceuticals,    137-B, Old Mahabalipuram Road, Karapakkam, Chennai-600 096,  India.

Sample is unsatisfactory due to colour variation of the powder and reconstituted solution among samples of the same batch.

Withhold the batch M14A093.

02

Aciclovir Sodium for Intravenous Infusion BP 250 mg (CIROVIR)

Ciron Drugs & Pharmaceuticals Pvt. Ltd, M.I.D.C., Tarapur, Boisar, Dist: Thane - 401 506, India.

Sample is unsatisfactory due to presence of a piece of glass inside a reconstituted vial.

Withdraw the batch 5E06058.

Withholding due to Adverse Reactions - July 2016

No.

Product

Manufacturer

Adverse Reaction reported

Decision

01

Cefuroxime Sodium for Injection USP 750 mg.

Reyoung Pharmaceutical Co. Ltd., NO. 06, Erlangshan Road,     Yiyuan County, Shandang Province, China.

Severe Anaphylactic Reactions, Hypotension, Bradycardia and Cardiac Arrest.

Withhold the product.

02

Ciprofloxacin Injections USP 200 mg / 100 ml (0.2% w/v).

Claris Lifesciences Ltd,         Chacharwadi, Vasana,         Ahmedabad - 382 213, India.

Several Allergic Reactions and a Death.

Withhold the product.

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - July 2016

No.

Product

Manufacturer

Reason

Decision

01

Amikacin Sulfate Injection USP 500 mg / 2 ml (AMPRO-500)

Protech Biosystems Pvt. Ltd, 145-146, Pace City-1, Sector-37, Gurgaon, Haryana, India.

Sample is unsatisfactory due to presence of visible floating particles in some intact vials.

Withdraw the batch AM-1505.

02

Erythromycin Stearate Tablets BP 500 mg (ERYCO-500)

Kopran Limited, Village: Savroli, Tal: Kalapur, Dist: Raigad-410202, India.

Sample does not confirm to BP specifications with respect to assay.

Withhold the batch LC10514001.

03

Azithromycin Tablets USP 250 mg (AZITH 250)

Zee Laboratories, Uchani, G. T. Road Karnal 13201, India.

Sample is unsatisfactory due to presences of broken tablets in intact container.

Withhold the batch ZET1746.

04

Streptokinase for Injection (Lyophilised)  for IV use 1,500,000 IU.

Health Biotech Limited, Nalagarh Road, Baddi-173205, Dist: Solan, (HP), India.

Sample is unsatisfactory with respect to the "constituted solution" test. (white, semisolid visible floating particles were observed, when the product was reconstituted with 0.9% w/w NaCl as per manufacturer's instructions)

Withhold the batch BQU 15002.

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - June 2016

No.

Product

Manufacturer

Reason

Decision

01

Adrenaline Injection BP 1 mg in 1 ml (ADRIVIT)

Vital Healthcare Pvt. Ltd,

Plot No. H-10, MIDC, Nashik-422007, India

Sample does not conform to BP specifications with respect to Characteristics.

Withhold the batch V 15166

02

Erythromycin Stearate Tablets BP 250 mg (FIRMAC-250)

Incepta Pharmaceuticals Ltd, Dhaka, Bangladesh.

Sample does not conform to BP specifications with respect to dissolution.

Withhold the batch 15004

03

Gliclazide Tablets BP 80 mg (DIAZIDE 80)

The Madras Pharmaceuticals, 137-B Old Mahabalipurm Road, Karapakkam, Chennai  600 096, India.

Sample is considered unsatisfactory due to dark brown patches in few tablets and inner lining of the container lid.

Discontinue to use the containers which show the defect.           Batch No. M 140812

04

Amikacin Sulfate Injection USP 500mg/2ml  (AMPRO-500)

Protech Biosystems Pvt Ltd, 145-146, Pace City-1, Sector-37, Gurgaon, Haryana, India.

Sample does not conform to manufacturer's specifications with respect to the description. (colourless)

Withdraw the batches               AM-1402, AM-1504 and AM-1405

05

Paracetamol Syrup 120 mg / 5ml - 100ml       (Panadol for Children Liquid)

Glaxo Wellcome Ceylon Ltd, 121, Galle Road, Kaldemulla, Moratuwa, Sri Lanka.

Sample does not conform to manufacturer's specifications with respect to appearance. (Presence of visible particles in intact containers)

Withdraw the batches           14G29, 14H33 and 14H30

Withholding due to severe adverse reactions - May 2016

No.

Product

Manufacturer

Faliure / Defect

Decision

01

Cefuroxime Sodium for Injection USP 750 mg

Reyoung Pharmaceutical Co. Ltd., No.06, Erlangshan road, Yiyuan country, Shandang province, China.

Severe anaphylaxis reactions, hypotension and cardiac arrest.

Withhold the batch 153052092

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - May 2016

No.

Product

Manufacturer

Reason

Decision

01

Paracetamol Tablet B.P. 500 mg (PARACIL)

Fourrts (India) Laboratories Pvt Ltd. Vandalur Rd., Kelambakkam-603103  Tamil Nadu, India.

Sample does not conform to BP specifications with respect to dissolution.

Withhold the batch C0363A.

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - April 2016

No.

Product

Manufacturer

Reason

Decision

01

Dobutamine Injection USP 250 mg / 20 ml (Dobufast)

Neon Laboratories Ltd, 28, Mahal Ind. Est. M. Caves Road, Andheri (East), Mumbai 400 093, India.

Sample does not conform to Manufacturer’s specifications with respect to description.

Withdraw the product.

02

Imipenem and Cilastatin for Injection           USP 500 mg

Swiss Parenterals Pvt. Ltd., Kerala,G.I.D.C. Nr.Bavla, Dist.Ahmedabad - 382 220, Gujarat, India.

Sample is considered unsatisfactory due to presences of a piece of glass in a reconstituted vial.

Withdraw the batch XB-14045

03

Succinylcholine Chloride for Injection            USP 100 mg (ZUSELAX)

ZAFA Pharmaceutical (Pvt) Ltd., L-1/B, Block-22, Federal “B” Industrial Area, Karachi-75950, Pakistan.

Sample is considered unsatisfactory due to presences of a piece of glass in an empty glass vial.

Withdraw the batch 86

04

Ferrous Sulphate Tablets BP 200 mg

Healthy Life Pharma Pvt. Ltd., Factory: N-31, M.I.D.C. Tarapur, Boisar, Dist.-Thane 401 506, India.

Sample is unsatisfactory as the sugar coating of most of the tablets in intact blisters are cracked.

Withhold the batch E 56091

Withholding due to severe adverse reactions - March 2016

No.

Product

Manufacturer

Faliure / Defect

Decision

01

Cefuroxime Sodium for Injection USP 750 mg.

Reyoung Pharmaceutical co. Ltd, No. 06, Langshan Road, Yiyuan County, Shandang Province, China.

Severe anaphylacxis reactions, bradycardia and hypotension.

Withhold the batches

153052087

153052089

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - March 2016

No.

Product

Manufacturer

Reason

Decision

01

Ferrous Sulfate Tablets USP 200 mg.

Ratnamani Healthcare Pvt. Ltd., Survey No: 750/1, Ahmedabad- Mehsana Highway, Vill: Indrad, Tal: Kadi, Dist: Mehsana, Gujarat, India.

Sample does not conform to USP specifications with respect to assay, dissolution tasts and colour variations of tablets.

Withdraw the Product.

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - February 2016

No.

Product

Manufacturer

Reason

Decision

01

Lignocaine Gel BP 2% w/w - 30 g

(LIGNOVIT GEL)

Vital Healthcare Pvt.  Ltd.

Works: Plot No. H-10, MIDC,Nashik-422007, India.

Regd.Off: 5/6, Shreyas 2nd Hasnabad Lane, Satacruz (W), Mumbai - 400 054, India.

Sample is unsatisfactory due to variations in the gel consistency among intact tubes.

Withdraw the batches

V112

V114

V116

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - January 2016

No.

Product

Manufacturer

Reason

Decision

01

Erythromycin Ethyl Succinate for Oral Suspension USP 125 mg/5 ml - 100ml

Ratnamani Healthcare Pvt. Ltd., Survey No: 750/1, Ahmedabad- Mehsana Highway, Vill: Indrad, Tal: Kadi, Dist: Mehsana, Gujarat, India.

Sample considered unsatisfactory due to separation of the suspension into two layers immediately after reconstitution and the lower layer appears to be clearer than the upper which is with granular contents.

Withdraw the batch RPE 160

02

Amikacin Sulphate Injection USP             500 mg /2 ml (AMPRO-500)

Protech Biosystems Pvt. Ltd,    145-14, Pace City 1, Sector-37, Gurgaon, Haryana, India.

Colour variation among vials of the same batch.

Withhold the batches  A-1402,    A-1405, A-1504

03

Adrenaline Injection BP                            1 mg in ml (ADRIVIT)

Vital Healthcare Pvt.  Ltd.

Works: Plot No. H-10, MIDC, Nashik-422007, India.

Regd.Off: 5/6, Shreyas 2nd Hasnabad Lane, Satacruz (W), Mumbai - 400 054, India.

Sample is unsatisfactory due to discoloration of contents in some ampoules.

Withhold the batch V14588

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - November 2015

No.

Product

Manufacturer

Reason

Decision

01

Streptomycin Injection BP 1 g / Vial (STREPTOVIT - 1000)

Vital Healthcare Pvt. Ltd,      Works: Plot No H-10, M.I.D.C., Satpur, Nashik 422007, India Regd.Off:5/6,Shreyas, 2nd Hasnabad Lane, Santacruz (West), Mumbai-400054, India.

Sample is unsatisfactory due to presence of visible particles in some intact vials after reconstitution.

Withdraw the batch VP15009

02

2% Lidocaine HCl with 0.0005% Epinehrine USP                                               30ml Multiple Dose Vials (JASOCAINE-A 2% Injection)

Jayson Pharmaceutical Ltd.,  Dhaka, Bangladesh.

Sample is considered unsatisfactory due to presence of visible particles in intact vials.

Withdraw the batches  339, 341

03

Co-Amoxiclav for Injection BP 600 mg      (N-CLAV 600 mg)

Ntin Lifesciences Ltd.               92-93, Sector-3, H.S.I.D.C., Industrial Area,   Karnal-132001, Haryana, India.

Sample is unsatisfactory due to presence of glass piece in a reconstituted vial.

Withdraw the batch NPE 492

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - October 2015

No.

Product

Manufacturer

Reason

Decision

01

Erythromycin Ethyl Succinate For Oral Suspension USP 125 mg/5 ml  100 ml / Pack

Ratnamani Healthcare Pvt. Ltd., Surway No: 750/1, Ahmedabad- Mehsana Hi Vill: Indrad, Tal: Kadi Dist: Mehsana, Gujarat, India.

Sample considered unsatisfactory due to separation of the suspension into two layers immediately after reconstitution and the lower layer appears to be clearer than the upper layer. which is with granular contents.

Withhold the batch

RPE 160

02

Ferrous Sulfate Tablets USP 200 mg

1000 Tablets / Pack

Ratnamani Healthcare Pvt. Ltd., Surway No: 750/1, Ahmedabad- Mehsana Hi Vill: Indrad, Tal: Kadi Dist: Mehsana, Gujarat, India.


Sample is considered unsatisfactory as variation of the colour was observed among tablets in intact pack.

Withhold the batches

FTE019

FTE005

FTE042

03

SPMC Famotidine Tablets USP 20 mg.

State Pharmaceuticals Manufacturing Corporation,  Ratmalana, Sri Lanka.

Sample is considered unsatisfactory as splitting /capping of tablets was observed when tablets were exposed to normal atmospheric conditions

Withdraw the batch

PRH02

04

Clomiphene Citrate Tablets 50 mg (Serophene).

Teva Pharmaceutical Industries Ltd, Israel.

Voluntary recall by the Manufacurer due to present of impurities

Reacall all the remaining stock of batches

S54013, S54015, S54017, S54030

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - September 2015

No.

Product

Manufacturer

Reason

Decision

01

Cephalexin for Oral Suspension USP 125 mg / 5 ml (KCEPHIN)

Kausikh Therapeutics (P) Ltd, Plot No. 6 & 7, Paraniputhur Village, Gerugambakkam, Chennai-602101, India.

Samples are unsatisfactory due to some manufacturing defects in containers and forming of orange brown lumps in some bottles.

Withdraw the product.

02

Povidone Iodine Solution BP 10% w/v.

Medicom Superdrugs Manufacturing, No. 221, Dharmapala Mawatha, Colombo 07, Sri Lanka.

Sample does not conform to BP specifications with respect to Assay.

Withdraw the batch

M-14-500

03

Paracetamol Tablets BP 500 mg.

Syncom Healthcare Ltd, D-42, UPSIDE Industrial Area, Selaqui, (Dehradun) 248197, Uttarakhand, India.

Sample is unsatisfactory due to presence of a piece of metal wire embedded in a tablet.

Withdraw the batch

ETS 003


Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - June 2015

No.

Product

Manufacturer

Reason

Decision

01

Co-Amoxiclav for Injection BP 1.2 g (ZAMOCLAV)

Zafa Pharmaceutical Laboratories (Pvt) Ltd,B-10, S.I.T.E., North Karachi, Karachi, Pakistan.

Sample is considered unsatisfactory due to following reasons.

  1. Brown substance spread on some vials.
  2. one reconstituted vial contained dark blue floating mass and fine glass piece.

Withdraw the product.

02

Erythromycin Stearate Tablets BP 250 mg

Incepta Pharmaceuticals Limited, Dhaka, Bangladesh.

Sample does not conform to BP specifications with respect to Dissolution.

Withhold the batch

13008.

03

Dobutamin Injection USP 250 mg / 20 ml. (DOBUFAST)

Neon Laboratories Ltd, 28, Mahal Ind. Estate, M. Caves Road, Andheri (East), Mumbai - 400 093, India.

Sample does not conform to manufacturer's specifications with respect to Description.

Manufacturer's specification: Clear pale colourless solution.

Sample observation: Clear pale yellow solution.

Withdraw the batch

88305

04

SPMC Famotidine Tablets USP 20 mg.

State Pharmaceuticals Manufacturing Corporation, Ratmalana, Sri Lanka.

Sample is considered unsatisfactory as splitting / capping of tablets was observed when tablets were exposed to normal atmospheric condition.

Withhold the batch

PRH02

05

Hydrocortisone for Injection 100 mg. Im / IV

(INTASONE)

Incepta Pharmaceuticals Limited, Dhaka, Bangladesh.

Sample does not conform to BP specifications with respect to Uniformity of conten & Assay.

Withdraw the batch

13035

06

Chloramphenicol Eye Drops BO 0.5% w/v     5 ml

Laborate Pharmaceuticals, E 11, Industrial Area, Panipat-132103, India.

Sample does not conform to BP specifications with respect to 2-Amino-1-(4-nitrophenyl) propane-1,3-diol.

Withdraw the batch

12CS14

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - May 2015

No.

Product

Manufacturer

Reason

Decision

01

Co-Amoxiclav for Injection BP 1.2 g (ZAMOCLAV)

Zafa Pharmaceutical Laboratories (Pvt) Ltd, B-10, S.I.T.E., North Karachi, Karachi, Pakistan.

Sample is considered unsatisfactory due to,

  1. Brown substance spread on some vials.
  2. Some vials were observed with cracks and irregularities on the upper part of the glass vial closer to the neck area.
  3. Poor GMP observed in the crimped metal cap.

Withhold the product.

02

Dobutamin Injection USP 250 mg / 20 ml. (DOBUFAST)

Neon Laboratories Ltd, 28, Mahal Ind. Estate, M. Caves Road, Andheri (East), Mumbai - 400 093, India.

Sample does not conform to manufacturer's specifications with respect to Description.

Withhold the batch

88305

03

Beclomethasone Dipropionate DP Caps 400 mcg (BECLATE DP CAPS 400)

Cipla Ltd, Malpur Dist. Solan, 173205, India.

Some Capsules are small in size and leakage of powder out of the capsules.

Withhold the  batch

B/N D43264

04

Paracetamol Oral Suspension 120 mg / 5 ml. (PANADOL FOR CHILDREN LIQUID)

Glaxo Wellcome Ceylon Ltd, 121, Galle Road, Kaldemulla, Moratuwa, Sri Lanka.

Sample does not conform to manufacturer's specifications with respect to appearance. (presence of visible particles in intact containers)

Withhold the batch

14G29

05

Erythromycin Stearate Tablets BP 250 mg Maxtar Biogenics, K-No. 705, Nalagarh Road, Malkumajra, Baddi - 173205, (H.P.), India.

Sample does not conform to BP specifications with respect to Assay.

Withhold the batch

MTES-1202

06

Hydrochlorothiazide Tablets BP 25 mg.

MSJ Industries (Ceylon) (Pvt) Ltd, 126, Aluth Mawatha Road, Colombo 15, Sri Lanka.

Sample does not conform to BP specifications with respect to Assay.

Withdraw the batch

131311

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - April 2015

No.

Product

Manufacturer

Reason

Decision

01

Meropenem for Injection USP 1000 mg (MEPRAN 1000 IV)

Kopran Limited, Village. Savroli, Tal. Khalapur, Dist. Raigad - 410 202, India.

Sample is considered unsatisfactory due to presence of a visible foreign floating particles in the reconstituted vials.

Withdraw the batch

LS87314003.

02

Potassium Chloride Extended Release Tablets USP 600 mg.

BDH Industries Limited, Akurli Road, Mumbai - 400 101, India.

Sample is considered unsatisfactory as brown / black stains were observed on the surface of some tablets in intact packs.

Withhold the batch 450913.

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - March 2015

No.

Product

Manufacturer

Reason

Decision

01

Nalidixic Acid Tablets BP 500 mg

Leben Laboratories Pvt. Ltd, L-4, Phase III, M.I.D.C., Aloka, 404 104, (Maharashtra), India.

Sample does not conform to BP specifications with respect to Dissolution.

Withhold batch T-12.

02

SPMC Folic Acid Tablets BP 1mg

State Pharmaceuticals Manufacturing Corporation, Ratmalana, Sri Lanka.

Sample does not conform to BP specifications with respect to Assay.

Withdraw the batches

PAK 10

PAK 13

03

Gastro Resistant Sodium Valproate Tablets BP 200mg

Centurion Laboratories (Centurion Remedies Pvt. Ltd), G 5 & G 6, Industrial Estate, Gorwa, Baroda, 39016, India.

Sample is considered unsatisfactory due to following observations

  1. Some tablets in intact metal strips are melted.
  2. Edges of some strips are not properly sealed & tablets are exposed to environment.

Withdraw the  batch

C-11002

04

Doxorubicin Hydrochloride Injection USP 10 mg / 5 ml (ADRIB)

Adley Foirmulations, Kotla, Barotiwala, 174 103, India.

Sample is considered unsatisfactory due to colour variation (bright red to brownish red) in the contents of vials.

Withhold the batches

ADC 4011DR

ADC 4013DR

05

Metformin Tablets BP 500 mg (X METTM 500 Tablets) Glenmark Pharmaceuticals Ltd, India.

Samples are considered unsatisfactory due to presence of light brown patches / spots on the surface of the tablets.

Withdraw the product.

06

SPMC Folic Acid Tablets BP 1mg

State Pharmaceuticals Manufacturing Corporation, Ratmalana, Sri Lanka.

Sample does not conform to BP specifications with respect to Assay.

Withdraw the batch

PAL 01

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - February 2015

No.

Product

Manufacturer

Reason

Decision

01

Folic Acid Tablets BP 1mg

State Pharmaceuticals Manufacturing Corporation

Sample does not conform to BP specifications with respect to Assay

Withhold batches

PAK 13

PAK 10

02

Dinaprostone Eur. P Vaginal Tablet 3mg

Aabiquasim Industries (Pvt) Ltd., Pakistan

Sample does not conform to BP specifications with respect to Assay

Withdraw batch

2U

03

Amoxycillin Oral Suspension BP 125mg/5ml

Belco Pharma, India

Sample is unsatisfactory due to following reasons

  1. Clumping of contents was observed in all containers received at NDQAL
  2. Reconstitution mark is printed on a separate sticker label & pasted on the body of the container above the label
  3. Inconsistancy of positioning of the sticker label with reconstitution mark was observed among the containers which  could lead to variation in reconsitued volume of suspension among different containers

Withhold batches

D-129A3

D-128A3

04

Domperidone Tablets BP 10mg

MSJ Industries(Ceylon)(Pvt) Ltd., Sri Lanka

Sample does not conform to BP specifications with respect to microbial contamination

Withdraw batch

140101

05

  1. i.            Merophenem for Injection USP 1g
  2. ii.            Sterilized water for injection BP 10ml
  3. i.            Zeiss Pharmaceuticals Pvt Ltd., India
  4. ii.            Nirma Ltd., India

Sample does not conform to BP specifications with respect to Oxidisable substances(Sterile water for injection BP)

Withhold batch

  1. i.            Merophenem for Injection USP(Batch No. 1714020)
  2. ii.            Sterilized water for injection BP(Batch No. 7502902)

06

Gastro Resistant Sodium Valproate Tablets BP 200mg

Centurian Laboratories, India

Sample is considered unsatisfactory due to following observations

  1. i.            Some tablets  in intact metal strips are not properly sealed & tablets are exposed to environment
  2. ii.            Edges of some strips are not properly sealed & tablets are exposed to environment

Withhold batch C-11002

07 Metformin Tablets BP 500 mg Bafna Pharmaceuticals Ltd., India Sample does not conform to manufacturer’s specifications with respect to appearance.

Withhold the batch

TC 569

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - January 2015

No.

Product

Manufacturer

Reason

Decision

01

Salbutamol Tablets BP 2 mg

BDH Industries Ltd., India

Sample does not conform to BP specifications with respect to friability

Withdraw batch

290413

02

Ibuprofen Tablets BP 200mg

Aravind Remedies Ltd., India

Sample is considered unsatisfactory as the colour of the coating of some tablets in intact pack is faded & some tablets were observed with irregularities such as chipping & capping

Withdraw batch

ET1302187

03

Paracetamol Tablets BP 500mg

Aravind Remedies Ltd., India

Sample is considered unsatisfactory due to presence of some broken tablets & tablets & tablets with chipping in an intact pack

Withhold batch

ET120546

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - December 2014

No.

Product

Manufacturer

Reason

Decision

01

2% Lidocaine HCL USP with 0.0005% Epinephrine USP Local Anaesthetic (Jasocaine-A 2% injection) 30ml multiple dose vial

Jayson Pharmaceuticals Ltd., Bangladesh

Sample does not conform to USP specifications with respect to assay

Withdraw batch  342

02

Povidone-iodine Solution BP 10%w/v;500ml(Relodine Cutaneous Solution)

Medicom Superdrugs, Dehiwala, Sri Lanka

Sample does not conform to BP specifications with respect to assay

Withdraw batches

07-C-15.500

05-L-13.500

08-L-13.500

03

Aspirin Tablets BP 300mg

Axon Drugs Pvt. Ltd., India

Withdraw product

04

Cloxacillin Oral Solution BP 125mg/5ml

Kopran Ltd., India

Sample does not conform to BP specifications with respect to following; The metal foil seal was not intact in some containers

Withdraw product

05

Glucose Intravenous Infusion BP 5% w/v(5D); 500ml

Nirma Ltd., India

Sample is unsatisfactory due to presence of floating particles in an apparently undamaged container

Withdraw batch 303014334

06

Furosemide Tablets BP 40mg

BDH Industries Ltd., India

Sample does not conform to BP specifications with respect to uniformity of weight

Withdraw batch

380213

07

 

Streptokinase Injection 1500000IU

Cadila Pharmaceuticals Ltd., India

Sample is not satisfactory due to  improper sealing of a vial

Withdraw batch

AN36E3001

08

Metformin Tablet BP 850mg

USV Ltd., India

Sample does not conform to BP specifications with respect to Assay

Withhold batch 26001902

09

Streptomycin Injection BP 1g

Vital Healthcare Pvt. Ltd., India

Sample is unsatisfactory due to presence of a glass piece in a vial

Withdraw batch

VP 14016

10

Aminophylline Injection BP 10ml

Vital Healthcare Pvt. Ltd., India

Sample does not conform to Manufacturer’s specifications with respect to description

Withdraw batch

V13549

11

Cefuroxime for Injection USP 750mg

Protech Biosystems Pvt. Ltd., India

Sample do not conform to USP specifications with respect to constituted solutions & one sealed vial observed without the rubber stopper

Withdraw product

 

 

12

Hydrocortisone Sodium Succinate for Injection BP 100mg

Galpha Laboratories Ltd., India

Sample is considered unsatisfactory due to presence of a piece of glass in a reconstituted vial

Withdraw batch

GHI3002A

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - December 2013

No. Product Manufacturer Reason Decision
01

Benzylpenicillin for Injection 1000000 IU

Vivek Pharmachem (India) Ltd, Jaipur, India

Vial with melted mass, presence

of a glass piece inside a reconstituted

vial

Withdrawal of the product  from use

02

Co-amoxiclav for Injection 600mg (Clavam)

Alkem Laboratories Ltd, Daman, India

Presence of hair-like structure in a reconstituted vial

Withhold of batch 3150258 from use as a precaution

03

Co-amoxiclav for Oral Suspension 156mg/5ml

AMN Life Sciences Pvt. Ltd, Gujarat, India

Failure in tests for ‘assay’ & ‘pH’, colour variation of the content

Withhold of batches AMNB052B12 &  AMNB039A12 from use as a precaution

04

Furosemide Tablets 40mg

BDH Industries Ltd, Mumbai, India

Discolouration of some tablets in intact containers

To withdraw packs containing discoloured tablets

05

Gentamicin Eye drops 0.3%

Belco Pharma, Bahadurgarh, India

Defective sealing of screw caps

Withdrawal of all batches manufactured before December 2012

06

Medroxyprogesterone acetate Injection 150mg (DEPO-PROVERA)

Pharmacia, Belgium

Failure in test for ‘pH’

Withdrawal of batch Z04820 from use

07

Phenoxymethylpenicillin Tablets 250mg (ARPECILLIN)

Arvind Remedies Ltd, Tamil Nadu, India

Failure in test for ‘friability’, tablet defects (broken tablets, black spots etc.)

Withdrawal of product from use

08

Streptokinase Injection 1500000IU (STPASE)

Cadila Pharmaceuticals Ltd, Dholka, India

Improper sealing of a vial

Withhold of batch AN 36 E3001 from use as a precaution

Withholds & Withdrawals Due to Quality Defects in Pharmaceuticals - October 2013

No. Product Manufacturer Reason Decision
01.

 

Cefalexin Oral Suspension 125mg/5ml (PHALEXIN)

Laborate Pharmaceuticals (India) Ltd, Panipat, India

Defective sealing, content formed into lumps

Withdrawal of batches DPXS-002, DPXS-003

02

Cefuroxime Axetil Tablets 500mg

Akum Drugs & Pharmaceuticals Ltd, Haridwar, India

Variation of colour of tablets

Withhold of batch PXAJ01 as a precaution

03

Diclofenac Gel 30g (DICLOLAB)

Laborate Pharmaceuticals (India) Ltd, Panipat, India

Failure in test for ‘assay’

Withdrawal of batch 11DLG14 from use

04

Paracetamol Tablets 500mg

Astron Ltd, Sri Lanka

Presence of a hair-like structure partially embedded in one tablet

Withdrawal of batch 3/11 5X1 from use

05

Promethazine Syrup 5mg/5ml, 100ml

Ciron Drugs & Pharmaceuticals Pvt. Ltd, Thane, India

Presence of foreign particles in solution

Withdrawal of batch E221454 from use

06

Sulbactam & Cefoperazone for Injection 1g (SULBACEF)

Biochem Pharmaceutical Industries Ltd, Mumbai India

Presence of a thread-like particles in a reconstituted vial

Withdrawal of batch ZB6126017 from use

Quality Defects in Pharmaceuticals Reported During the month of September 2013

No. Product Manufacturer Reason Decision
01.

 

Aciclovir Injection 250mg

Naprod Lifesciences, Mumbai, India

Presence of glass particle inside

a reconstituted vial

Withdrawal of batch

NP3019A from use

02.

Benzylpenicillin for Injection 1000000 IU

Vivek Pharmachem (India) Ltd, Jaipur, India

Vial with melted mass

Withdrawal of batch

BPI 11130  from use

03.

Betamethasone & Neomycin Eye, Ear & Nasal Drops (PRO-DROP N)

Eurolife Healthcare, Uttarakhand, India

Content discoloured into a brownish

yellow solution

Withhold of batch 13-2001 from use as a precaution

04.

Captopril Tablets 25mg (ACEPRIL)

Bafna Pharmaceuticals Ltd, Chennai, India

Failure in test for ‘assay’ and ‘Captopril

disulphide’

Withdrawal of batch TE2801 from use

05.

Cefotaxime for Injection 1g

Kilitch Drugs (India) Ltd, Simour, India

Presence of white powdery substance

on surface of rubber stopper

Withdrawal of batches 2412053 and 2412062 from use

06.

Ceftriaxone for Injection 1g

Karnataka Antibiotics & Pharmaceuticals, Bangalore, India

Failure in test for ‘uniformity of dosage

units’

Withdrawal of batch 4402711 from use

07

Chlorpromazine Injection 50mg/2ml

Atlantic Laboratories Corporation, Bangkok, Thailand

Colourless solution had turned to pale

yellow

Withdrawal of affected vials

08.

Cloxacillin sodium for Injection 250mg

Elysium Pharmaceuticals Ltd, Gujarat, India

Presence of foreign particles adhered to glass wall of a reconstituted vial

Withdrawal of batch CC2004 from use

09.

Diclofenac Gel 30g (DICLOLAB)

Laborate Pharmaceuticals (India) Ltd, Panipat, India

Failure in test for ‘assay’

Withdrawal of batch 11DLG14 from use

10.

Enalapril Maleate Tablets 5mg

Medley Pharmaceuticals, Daman, India

Failure in test for ‘assay’

Withhold of batch D10118 from use as a precaution

11.

Mebendazole Tablets 100mg (MeEDAZOLE)

Unibios Laboratories Ltd, Thane, India

Failure in test for ‘Microbial Enumeration Test’

Withdrawal of product from use

12.

Mefenamic Acid Tablets 250mg

Blue Cross Laboratories Ltd, Goa, India

Presence of a hair-like structure inside an intact blister of one tablet

Withdrawal of batch HKX1218 from use

13.

Metronidazole Injection 0.5%, 100ml

Claris Lifesciences Ltd, Ahmedabad, India

Discolouration of solution in intact containers

Withdrawal of batch A620119 from use

14.

Multivitamin drops, Paediatric 15ml (HOVITE-Z)

Raptakos, Breit & Co Ltd, Mumbai, India

Leakage of content from screw caps

Withdrawal of batches T13001 & T13002 from use

Quality Defects in Pharmaceuticals Reported During the month of August 2013

No. Product Manufacturer Reason Decision
01

Phenylephrine Hydrochloride Ophthalmic Solution USP 2.5% (AUROPHENYL)

Aurolab, Madurai, India

Presence of brown stains on screw threads & on inner side of screw caps  due to leakage of the solution

Withdraw batch 1J415 from the market

02.

Promethazine Hydrochloride Injection USP 25mg/ml

Alvita Pharma, Vadodara, India

Presence of forein floating particles in in ampoules; Presence of aglass piece in an ampoule

Withdraw batches RE3036 & RE3037 from the market

03.

Sodium chloride Intravenous Infusion BP 0.9%, 500ml

Nirma Ltd, India

Presence of brown colour floating particles in an intact container

Withdraw batch 303214608 from the market

Quality Defects in Pharmaceuticals Reported During the month of July 2013

No. Product Manufacturer Reason Decision
01

Ampicillin Sodium for Injection BP 250mg (NEOCILLIN)

Neon Laboratories Ltd, Thane, India

Failure in test for ‘water’

Withdraw batch 455484 from the market

02.

Captopril Tablets BP 25mg (ACEPRIL)

Bafna Pharmaceuticals Ltd, India

Failure in test for ‘assay’

Withhold batch TE-2670 from use as a precaution

03.

Cefuroxime for Injection USP 250mg (INFRID 250mg)

Medicraft Pharmaceuticals (Pvt) Ltd, Pakistan

Presence of a piece of glass inside a vial

Withdraw batch IP023 from the market

04.

Domperidone Suspension, 100ml (PERIDONE)

Unijules Life Sciences Ltd, Nagpur, India

Failure in test for ‘microbial contamination’

Withdraw batch 0723G1202 from the market

05.

Meropenam for Injection USP 1g (MAKPENEM)

Makcur Laboratories Ltd, Gujarat, India

Presence of brown stains on rim of the vials and area of rubber stopper in contact with rim; presence of floating particles in reconstituted vials

Withdraw batches EP119SG & EP120SG

from the market

06.

Oxytocin Injection BP 5 IU

Apurva Biopharm Inc, India

Labeling deficiency

Withdraw batch SAP27 from the market

Quality Defects in Pharmaceuticals Reported During the month of June 2013

No. Product Manufacturer Reason Decision
01

Ampicillin Sodium for Injection BP 250mg (NEOCILLIN)

Neon Laboratories Ltd, Thane, India

Presence of a piece of glass inside a reconstituted vial

Withdraw batch 455425 from the market

02.

Chloramphenicol Eye drops BP 0.5% (MB-CHLOR)

MBL Pharma, Pakistan

Failure in test for 2-Amino -1-(4-nitrophenyl) propane-1, 3-diol

Withhold batch 050412 from use as a precaution

03.

Cloxacillin Sodium for Injection 500mg

Karnataka Antibiotics & Pharmaceuticals, India

Presence of a piece of glass inside a reconstituted vial

Withdraw batch 1500612 from the market

04.

Co-amoxyclav Tablets USP 375mg

Galpha Laboratories Ltd, Daman, India

Inflated tablet pockets emanating bad smell, discoloured tablets

Withdraw the product  from the market

05.

Dextrose Injection USP 50%, 50ml

Atlantic  Laboratories Corporation Ltd, Thailand

Presence of visible floating particles in intact ampoules

Withdraw the product  from the market

06.

Ferrous Sulphate Tablets 200mg

BDH Industries Ltd, India

Failure in test for ‘disintegration’

Withhold batch 300411 from use as a precaution

07.

Mebendazole Tablets USP 100mg

Unibios Laboratories Ltd, Thane, India

Failure in test for ‘Microbial Enumeration Test’

Withhold batches MA-217, MA-218 and MA-219 from use as a precaution

08.

Meropenam for Injection USP 500mg (RONEM)

Venus Remedies Ltd, India

Presence of brown stains on rim of the vials and area of rubber stopper in contact with rim

Withdraw batch XV3C732 from the market

09.

Metformin Tablets BP 500mg

Glenmark Pharmaceuticals Ltd, Mumbai, India

Presence of light brown patches on surface of tablets

Withhold batch 12374 from use as a precaution

10.

Vancomycin Hydrochloride for Injection USP 1000mg

Elysium Pharmaceuticals Ltd, Gujarat, India

Some vials were out of specifications for ‘filled weight per vial’

Withdraw batch AN12001 from the market

11.

Water for Injection BP, 10ml

Parenteral Drugs (India) Ltd, Solan, India

Presence of visible floating particles in intact ampoules

Withdraw batches 1WE-108, 1WE-117, 1WE-118, 1WE-119 from the market

Quality Defects in Pharmaceuticals Reported During the month of May 2013

No. Product Manufacturer Reason Decision
01

Ampicillin Sodium for Injection BP 250mg (NEOCILLIN)

Neon Laboratories Ltd, Thane, India

Failure in test for ‘water’

Withdraw batch 455434 from the market

02.

Co-amoxiclav for Injection 1.2g (MAKCLAVE)

Makcur Laboratories Ltd, Gujarat, India

Presence of a hair-like structure between rubber stopper and crimped metal cap

Withhold batch EP115SG from use as a precaution

03.

Dextrose Injection USP 50%, 50ml

Atlantic  Laboratories Corporation Ltd, Thailand

Presence of visible floating particles in intact ampoules

Withdraw batches 103539 & 103545  from the market

04.

Furosemide Tablets BP 40mg

BDH Industries Ltd, Mumbai, India

Discolouration of tablets

Withdraw batch 070911 from the market

05.

Oxytocin Injection BP 5 IU

Apurva Biopharm Inc, India

Labeling deficiency

Withdraw batch SAP15 from the market

Quality Defects in Pharmaceuticals Reported During the month of April 2013

No. Product Manufacturer Reason Decision
01

Amoxicillin Oral Suspension USP 125mg/5ml (NESMOX)

Nestor Pharmaceuticals Ltd, Faridabad, India

Lump formation; colour variation; improper sealing

Withdraw the

product from the market

02.

Benzylpenicillin for Injection BP 1,000,000 Units

Vivek Pharmachem (India) Ltd, Jaipur, India

Vial with melted mass; vial without a rubber stopper

Withhold batches BPI 11142 & BPI 11139from use as a precaution

03.

Cefuroximefor Injection USP 750mg

Umedica Laboratories Ltd, Gujarat, India

Presence of a foreign particle inside a reconstituted vial

Withdraw batch V32076  from the market

04.

Cephalexin for Oral Suspension USP 125mg/5ml (ARCEIN)

Arvind Remedies Ltd, Tamil Nadu, India

Appearance (colour/nature) of the content does not conform to manufacturer’s specification; colour variation in reconstituted product

Withdraw the product from the market

05.

Chloramphenicol Eye drops 0.5%

Jayson Pharmaceuticals Ltd, Bangladesh

Failure in test for 2-Amino -1-(4-nitrophenyl)propane-1, 3-diol

Withdraw batch 055 from the market

06.

Cloxacillin for Injection BP 250mg

Elysium Pharmaceuticals Ltd, Gujarat, India

Presence of a foreign particle inside a reconstituted vial; vial without a rubber stopper

Withdraw batches CC2002 & CC2012  from the market

07.

Co-amoxiclav for Injection 600mg (CLAVAM 600mg)

Alkem Laboratories Ltd, Mumbai, India

Failure in test for water

Withhold batch 2150650 from use as a precaution

08.

Co-amoxiclav for Oral Suspension USP 156.25mg/5ml

Alkem Laboratories Ltd, Daman, India

Description (colour of powder and suspension) does not conform to manufacturer’s specifications

Withdraw batches 1161010 & 1161011  from the market

09.

Co-amoxiclav for Oral Suspension USP 156.25mg/5ml

AMN Life Sciences Ltd, Gujarat, India

Colour variation in powder and suspension; improper sealing

Withhold batch AMNB050B12 from use as a precaution

10.

Erythromycin Ethyl succinate Oral Suspension 125mg/5ml

Alembic Ltd, Vadodara, India

Discolouration of reconstituted suspension; defective closure

Withdraw batches 11093713 & 11093706 from the market

11.

Glibenclamide Tablets BP 5mg

Inga Laboratories Ltd, Mumbai, India

Failure in tests for assay

Withhold the batch DT1124 from use as a precaution

12.

Medroxyprogesterone Acetate , Sterile Suspension USP 150mg/ml (DEPO-PROVERA)

Pharmacia NV/SA, Belgium

Failure in tests for pH

Withhold batch Z04820 from use as a precaution

13.

Metoclopramide Tablets BP 10mg (REGURG)

Leben Laboratories Pvt. Ltd, Akola, Maharashtra, India

Failure in tests for friability

Withhold batches T-6150, T-6160, & T-6170 from use as a precaution

14.

Midazolam Injection BP 5mg/1ml

Troikaa Pharmaceuticals Ltd, Gujarat, India

Presence of an empty ampoule with a tiny hole on top

Withdraw batch B03145 from the market

15.

Paracetamol Tablets BP 500mg (KELVIN)

Leben Laboratories Pvt. Ltd,  Nagpur, India

Discolouration of tablets

Withdraw batch T-872 from the market

16.

Salbutamol Pressurized Inhalation BP 100mcg (SALBUTIS 100)

Shandong Jewim Pharmaceutical Co Ltd, China

Presence of melted mass on crimp seal of canisters; failure to release drug on actuation

Withdraw batch 100315 from the market

17.

Sodium Valproate Tablets 200mg (VALSTAL-200)

Stallion Laboratories Pvt. Ltd, Gujarat, India

Melted tablets in intact metal strips; presence of empty blisters

Withdraw the

product from the market

18.

Vit E 125mg, Vit C 500mg and Vit A 10mg Tablets

(Once A day AX Antioxidant)

CCL Pharmaceuticals (Pvt.) Ltd, Lahore, Pakistan

Cracked coating in some tablets inside intact blisters; easily breakable tablets

Withhold batch EY273 from the market

 

Withhold & Withdrawals Due to Quality Defects in Pharmaceuticals - March 2013

No. Product Manufacturer Reason Decision
01

Acetylcystene Injection 20%, 10ml

Star Drugs & Research Labs Ltd, Hosur, India

Failure in test for acidity or alkalinity

Withdraw batch 12017101 from the market

02

Amoxicillin Oral Suspension BP 125mg/5ml (AMOXYLAB-125)

Laborate Pharmaceuticals India Ltd, Panipat, India

Content were lumped, colour variation in powder & suspension, improper sealing

Withdraw the

product from the market

03

Beclometasone Pressurized Inhalation BP 100mcg (BCLOTIS 100)

Shandong Jewim Pharmaceutical Co Ltd, China

Presence of melted mass on crimp seal of canisters; failure to release drug on actuation

Withdraw batches 100338 & 100725 12017101 from the market

04

Gentamycin Eye drops 0.3% (GARACIN)

Belco Pharma, Haryana, India

Faulty crew caps,; presence of stains on neck area of bottles

Withdraw batches D-007G2, D-008G2 & D-009G02 from the market

05

Hydrogen Peroxide Solution

Central Drugs & Pharmaceuticals, Chennai, India

Failure in test for assay; presence of visible particles in the solution; colour of the solution does not conform to manufacturer’s description

Withdraw the product from the market

06

Leucovorin Calcium Injection USP 15mg/2ml (LEUCOWEL-15)

Getwell  Pharmaceuticals, Haryana, India

Presence of visible particles

Withdraw batch 2GLE05 from the market

07

Phenytoin Tablets 50mg

Zim Laboratories Ltd,  Nagpur, India

Cracked tablets in intact containers

Withdraw batch D101 from the market

08

Sodium Valproate Tablets 200mg (S-VALAPRO)

AMN Life Sciences Pvt. Ltd, Gujarat, India

Melted tablets in intact metal strips

Withhold batch AMN002J11 from use as a precaution

Withhold & Withdrawals Due to Quality Defects in Pharmaceuticals - February 2013

No. Product Manufacturer Reason Decision
01

Metformin Tablets BP 500mg

Venous International, Mumbai, India

Uncoated tablets (does not conform to BP specifications; have to be coated)

Withdraw batch VM-023 from the market

02

Paracetamol Tablets BP 500mg (KELVIN)

Leben Laboratories Pvt. Ltd,  Nagpur, India

Discolouration of tablets

Withdraw batch T-902 from the market

03

Salbutamol Tablets BP 2mg

BDH Industries Ltd, India

Failure in test for assay

Withdraw batch 110311 from the market

 

Withhold & Withdrawals Due to Quality Defects in Pharmaceuticals - January 2013

No. Product Manufacturer Reason Decision
01

Acetylcystene Injection 20%, 10ml

Star Drugs & Research Labs Ltd, Hosur, India

Failure in test for acidity or alkalinity

Withhold batch 12017101 from use as a precaution

02

Benzylpenicillin for Injection 1,000,000 Units

Elysium Pharmaceuticals Ltd, Gujarat, India

Corroded metal caps, presence of a white powdery substance on some metal caps

Withdraw the 
product from the market

03

Cephalexin for Oral Suspension (APALEXIN125mg)

Apurva Biopharm Inc, India

Formation of lumps in intact bottles, appearance (colour) of the content does not conform to manufacturer’s specification, colour variation in reconstituted
product, different  storage temperatures indicated on PIL and labels

Withdraw the 
product from the market

04

Cloxacillin for Injection 250mg (BICLOX)

Biochem Pharmaceutical Industries, Daman, India

Presence of a piece of glass inside a reconstituted vial

Withdraw the 
product from the market

05

Co-amoxiclav for Injection 1200mg (ELCLAVE 1200)

Elysium Pharmaceuticals Ltd, Gujarat, India

Failure in test for water

Withhold batch EC 1002 from use as a precaution

06

Co-amoxiclav for Oral Suspension 156.25mg in 5ml

Alkem Laboratories, Daman, India

Colour of the granular powder does not conform to manufacturer’s description

Withdraw batch 1160162 from the market (previously withheld batch)

07

Furosemide (Frusemide) Injection 20mg/2ml

Star Drugs & Research Labs Ltd, Hosur, India

Failure in tests for identification and acidity or alkalinity

Withhold the product from use as a precaution

08

Hydrogen Peroxide Solution

Central Drugs & Pharmaceuticals, Chennai, India

Colour of the solution does not conform to manufacturer’s description

Withhold batch 172 from use as a precaution

09

Meropenam Injection 500mg

Neon Laboratories Ltd, Mumbai, India

Presence of a glass like particle inside a reconstituted vial

Withhold the product from use as a precaution

10

Phenytoin Tablets 50mg

Zim Laboratories Ltd,  Nagpur, India

Cracked tablets in intact containers

Withhold batch D101 from use as a precaution

11

Sodium Valproate Tablets 200mg (VALSTAL-200)

Stallion Laboratories Pvt. Ltd, Gujarat, India

Melted tablets in intact metal strips

Withdraw packs containing melted tablets

12

Vitamin E 125mg, Vitamin C 500mg and Vitamin A 10mg Tablets
(Once A day AX Antioxidant Tablets)

CCL Pharmaceuticals (Pvt.) Ltd, Lahore, Pakistan

Cracked coating in some tablets inside intact blisters; easily breakable tablets

Withhold batch EY273 from use as a precaution

Quality Defects in Pharmaceuticals Reported During the month of December 2012

No. Product Manufacturer Reason Decision
01

Amoxicillin Oral Suspension 125mg in 5ml (AMOXYLAB-125)

Laborate Pharmaceuticals India Ltd, Panipat, India

Samples do not conform to manufacturer’s definition (content clumped and stuck to wall of bottles)

Withdraw batch 
BALD-006 from the market

02

Ampicillin Sodium for Injection 250mg
(ELICILLIN 250)

Elysium Pharmaceuticals Ltd, Gujarat, India

Failure in test for water

Withdraw batch 
EL 1002 from the market

03

Benzylpenicillin for Injection 1,000,000 Units

Elysium Pharmaceuticals Ltd, Gujarat, India

Corroded metal caps, presence of a white powdery substance on some metal caps

Withdraw batch 
BC 1008 from the market

04

Cloxacillin Oral Suspension 125mg/5ml, 100ml (CLOXIN)

Kopran Ltd,Raigad, India

Failure in test for assay

Withdraw batches T6581008 and T6581011 from the market

05

Co-amoxiclav Oral Suspension 156.25mg/5ml, 100ml

Alkem Laboratories Ltd, Daman, India

Samples do not conform to manufacturer’s description with respect to colour of powder and suspension

Withdraw batch 1160162 from the market

06

Domperidone Oral Suspension 1mg in 1ml (PERIDONE)

Unijules Life Sciences Ltd, Nagpur, India

Failure in test for microbial contamination

Withdraw batch 0723C1202 from the market

07

Gentamicin Eye Drops 0.3% (GARACIN)

Belco Pharma, Bahadurgarh, India

Screw caps of most bottles could be opened without breaking ‘tamper-evident’ security feature

Withhold batch D-007G2 from use as a precaution

08

Hydrogen Peroxide Solution

Central Drugs & Pharmaceuticals, Chennai, India

Presence of visible particles in some intact bottles

Withdraw batches 173 and 181 from the market

09

Leucovorin Calcium Injection 15mg in 2ml (LEUCOWEL-15)

Getwell Pharmaceuticals, Haryana, India

Presence of visible particles in some intact ampoules

Withdraw batch 2GLE04 from the market

10

Metformin Tablets 500mg

Glenmark Pharmaceuticals, Mumbai, India

Presence of light brown patches/spots on surface of tablets

Withhold batches 12380 and, 12394 from use as a precaution

11

Pralidoxime chloride for Injection 1g (NEOPAM)

Troikaa Pharmaceuticals Ltd, Gujarat, India

Presence of visible particles in some intact vials

Withdraw batch N04120 from the market

12

Salbutamol Tablets 2mg

BDH Industries Ltd, Mumbai, India

 

Failure in test for assay

Withhold batch 110311 from use as a precaution

13

Sodium Valproate Tablets 200mg (VALSTAL-200)

Stallion Laboratories Pvt. Ltd, Gujarat, India

Presence of empty blister in intact metal strips

Withdraw batches S-19 and S-08 from the market

Quality Defects in Pharmaceuticals Reported During the month of November 2012

No. Product Manufacturer Reason Decision
01. Cefuroxime axetil for Oral Suspension 125mg/5ml, 100ml (CEFUR-125) Cassel  Research Laboratories Pvt. Ltd., Chennai, India Presence of black patches stick to bottle wall, inside intact bottle Withdraw batch 
ET-05-11002 from the market
02. Co-amoxiclav Oral Suspension 156.25mg/5ml, 100ml (NOVACLAV) Cipla Ltd, Mumbai, India Failure in tests for assay and deliverable volume, colour variation in contents among bottles Withdraw the product from the market
03. Co-amoxiclav Oral Suspension 156.25mg/5ml, 100ml Alkem Laboratories Ltd, Daman, India Samples do not conform to manufacturer’s description with respect to colour of powder and suspension Withhold batch 1160164 from use as a precaution
04. Cyclosporine Capsules 100mg and 50mg Alvita Pharma Pvt. Ltd, Mumbai, India Failure in test for content uniformity Withdraw the two products from the market
05. Meropenam for Injection 500mg (MAKPENEM) Makcur Laboratories Ltd, Gandhinagar, India In some vials, content were stuck to bottom surface Withdraw batch       EP44S from the market
06. Metformin Tablets 500mg AMN Life Sciences Pvt. Ltd, Ahmedabad, India Failure in test for assay and dissolution Withdraw the product from the market
07. Salbutamol Pressurised Inhaler 100mcg Shandong Jewim Pharmaceutical Co Ltd, Shandong, China Presence of melted mass on crimped seal/content were not released when actuated, in some canisters Withhold batch 100315 from use as a precaution
08. Vincristine sulfate for Injection 1mg Naprod Life Sciences Pvt. Ltd, Thane, India Shrinkage of lyophilized mass/almost empty vials Withdraw batches NN1272 and NN 1273 from the market

Quality Defects in Pharmaceuticals Reported During the month of October 2012

No. Product Manufacturer Reason Decision
01. Co-amoxiclav Oral Suspension 12.5mg/5ml, 100ml (NOVACLAV) Cipla Ltd,
India
Failure in test for assay, colour variation on contents among bottles Withdraw batches BM1061, BM1062 and BM0333 from the market
02. Erythromycin Stearate for Oral Suspension 125mg/5ml, 100ml Alembic Ltd., Varodara – 390 003, India Failure in test for assay Withdraw batches 10093742 and 11093711 from the market
03. Fluphenazine deconate Injection 25mg/ml Star Drugs & Research Labs Ltd, India Not conforming to manufacturer’s description (change in colour of the solution) Withdraw batch CFDI-001 from the market
04. Lignocaine Hydrochloride Gel 2%, 30G Central Drugs & Pharmaceuticals,
Chennai – 602 101, India
Failure in test for
assay
Withdraw the product from the market
05. Metformin Tablets 500mg Glenmark Pharmaceuticals, Mumbai – 400 026, India Due to presence of light brown patches/spots on surface, extending to core of tablets Withhold batch
12399 from use as a precaution

Quality Defects in Pharmaceuticals Reported During the month of September 2012

No. Product Manufacturer Reason Decision
01. Amoxicillin for Oral Suspension 125mg/5ml (AMYN) Kopran Ltd,
Raigad – 410 202, India
Inadequate directions for reconstitution, on label Withhold batch S3521056 from use as a precaution
02. Cefuroxime Axetil for Oral Suspension 125mg/5ml (CEFUR-125) Cassel Research Laboratories Pvt. Ltd., Chennai – 600 032 India Presence of black patches stick to bottle wall, inside intact bottles Withhold batch
ET-05-11002 from use as a precaution
03. Co-amoxiclav Injection 1.2g (KLAVMOX) Kilitch Drugs (India) Ltd, Thane, India Presence of a glass piece in a reconstituted vial Withdraw batch 2312001 from the market
04. Gentamicin Eye drops 0.3%, 5ml Belco Pharma, Bahadurgarh -124 507, Haryana, India Bottles are not properly sealed Withhold batches D-008G2 and D-009G2 from use as a precaution
05. Hydrogen peroxide Solution Central Drugs & Pharmaceuticals,
Chennai – 602 101, India
Presence of visible particles in intact bottles Withhold batches 173 and 181 from use as a precaution
06. Metformin Tablets 500mg AMN Lifesciences, Ahmedabad, Gujarat, India Failure in test for assay Withdraw batches 1257, 1259, 1261 from the market
07. Metformin Tablets 500mg Venus International, Mumbai – 400 062, India Deviation from description (content melted and turned from white to yellow) Withdraw batch VM-11 from the market
08. Povidone-Iodine Solution 10%, 500ml Central Drugs & Pharmaceuticals,
Chennai – 602 101, India
Failure in test for assay Withdraw batch PI09 from the market

Quality Defects in Pharmaceuticals Reported During the month of August 2012

No. Product Manufacturer Reason Decision
01. Amoxicillin Syrup 125mg/5ml Laborate Pharmaceuticals, Panipat, - 1320103, India. Deviation from definition (clumping of content) Withhold batch NXDN – 150 from use
02. Amoxicillin Syrup 125mg/5ml Nestor Pharmaceuticals, Faridabad – 121 001, India Deviation from definition (clumping of content) Withhold batch BALD – 006 from use
03. Co-amoxiclav Injection 1.2g Galpha Laboratories, Mumbai – 400 018, India Failure in test for assay, colour variation of contents among vials Withhold batch 0161585 from use
04. Co-amoxiclav Injection 1.2g Galpha Laboratories, Mumbai – 400 018, India Presence of foreign particles in reconstituted solution of some vials Withdraw batch CAHI10003A from the market
05. Coamoxiclav Oral suspension 12.5mg/ 100ml Cipla Ltd, India Failure in test for assay Withdraw batch BM0333
06. Gripe Water, 130ml Promed Laboratories, Indore – 452 006, India Presence of foreign matter suspected to be insect body parts in one intact bottle Withdraw batch PWE 0008 from the market
07. Ifosfamide for Injection with Mesna Injection Biochem Pharmaceutical Industries, Daman (U.T.), 396 210, India Deviation from description (content melted and turned from white to yellow) Discontinue packs with defective content
08. Lignocaine Hydrochloride Gel 2%, 30G Central Drugs & Pharmaceuticals, Chennai – 602 101, India Failure in test for assay Withdraw batches 02, 07, 09 and 13 from the market
09. Meropenam Injection 500mg Makcur Laboratories, Gandhinagar, India Content stuck to bottom of some intact vials Withhold batch EP 44 S from use
10. Olanzapine Tablets 10mg The Madras Pharmaceuticals, Chennai – 600 096, India Deviation from description (colour of tablets changed from yellow to cream/beige/light brown) Withdraw batches M110332 and M110335 from the market
11. Paracetamol Tablets 500mg Laborate Pharmaceuticals, Nariwala, India Failure in test for Uniformity of weight Withdraw batch BPOT007 from the market

Quality Defects in Pharmaceuticals Reported During the month of July 2012

No. Product Manufacturer Reason Decision
01. Cefuroxime for Injection 750mg Swiss Parenterals Pvt. Ltd, Ahmedabad – 382 220, India. Presence of a piece of glass inside a reconstituted vial To withdraw batch XB-12029 from market
02. Calcium gluconate Injection 10% Star Drugs & Research Labs Ltd, Hosur – 635 109, India. Presence of visible particles in intact ampoules To withdraw batch 11010302 from market
03. Cephalexin Oral Suspension 125mg / 5ml Kaushik Therapeutics, Thane (W) - 400610, India. Contents do not dissolve properly To discontinue bottles that show the defect
04. Chlorpheniramine Tablets 4mg Nestor Pharmaceuticals Ltd, Faridabad - 121 001, India. Failure in the tests for related substances & friability To withdraw the product from the market
05. Cloxacillin Injection 250mg Makcur Laboratories, Gandhinagar, Gujarat, India. Failure in the test for water; sealing defects, presence of foreign objects in reconstituted vials To withdraw the product from the market
06. Coamoxyclav for Injection 1.2G AMN Life Sciences, Gujarat, India. Failure in the test for water To withdraw batch SAC-10110 from the market
07. Coamoxyclav for Injection 1.2G Ranbaxy Laboratories, Dewas – 455 001, India. Failure in the tests for assay & water To withdraw the product from the market
08. Domperidone Oral Suspension 5mg/5ml, 100ml Unijules Life Sciences Ltd, Nagpur – 441 501 (M.S.), India. Failure in the tests for microbial contamination To withdraw batch 0723H1103 from the market
09. Glucose Injection 50%, 50ml Nirma Ltd, Gujarat - 382 150, India. Presence of visible particles To withdraw the product from the market
10. Glyceryl trinitrate Tablets 500mcg Actavis, Barnstaple, EX 32 8 NS, United Kingdom Failure in the test for disintegration To withdraw batches GF832 & GF834 from the market
11. Isopropyl Alcohol Safe House, Kalutara, Sri Lanka. Failure in the test for identification To withdraw batch 22/BL from the market
12. Metformin Tablets 500mg Venus International, Mumbai – 400 062, India. Deviation from definition (uncoated tablets) To withdraw batch VM-10 from the market
13. Phenoxymethylpenicillin Tablets 250mg Arvind Remedies Ltd, Kakkalur – 602 003, Tamil Nadu, India. Failure in the test for friability; tablet defects To withhold batch BT 110814 from use as a preliminary precaution
14. Povidone-Iodine Solution 10% Central Drugs & Pharmaceuticals, Chennai – 602 101, India. Failure in the test for assay To withhold batch PI 09 from use as a preliminary precaution
15. Vincristine sulfate Injection 1mg Naprod Lifesciences, Thane, India. Shrinkage of lyophilized mass; almost empty vials To withhold batches NN1272, NN1273 from use as a preliminary precaution

Quality Defects in Pharmaceuticals Reported During the month of June 2012

No. Product Manufacturer Reason Decision
01. Aminophylline Injection 250mg in 10ml Star Drugs & Research Labs Ltd, Hosur – 635 109, India. Presence of crystal like particles in intact ampoules To withdraw batch 110173301 from market
02. Ampicillin Injection 250mg Nestor Pharmaceuticals, India. Failure in the test for assay and water To withhold batch ALIN-21 from use as a preliminary precaution
03. Aspirin Tablet 300mg BDH Industries Ltd, Mumbai – 400 101, India. Crystal formation, strong smell and sticking of tablets To withdraw batch 320110 from market
04. Cefuroxime for Injection 750mg Swiss Parenterals Pvt Ltd, Ahmedabad – 382 220, India. Presence of a piece of glass inside a reconstituted vial To withdraw batch XB-11113 from market
05. Cephalexin Oral Suspension 125mg/ 5ml (APALEXIN 125mg) Apurva Biopharm Inc, Thane (W) - 400610, India. Formation of lumps in intact bottles To withhold batches DS102 & DS104 from use as a preliminary precaution
06. Cloxacillin Oral Solution 125mg in 5ml, 100ml Kopran Ltd, Raigad – 410 202, India Failure in the test for assay; formation of lumps in some bottles To withhold batch T6581011 as a preliminary precaution; to discontinue bottles of which the content had formed to lumps
07. Coamoxyclav for Oral Suspension 12.5g (NOVACLAV) Cipla Ltd, India. Failure in the test for assay; colour variation in dry powder To withhold batches BM1061, BM1062 and BM0333 from use as a preliminary precaution
08. Cyclophosphamide for Injection 200mg (COMIDE) Apurva Biopharm Inc, Thane (W) - 400610, India. Content were discoloured and melted To withhold batch PCYBKAO03 from use as a preliminary precaution
09. Glucose Injection 50%, 50ml Nirma Ltd, Gujarat, 382 150, India. Presence of visible particles To withdraw batch 5100072 from market
10. Levocetrizine Tablets 5mg (LIZA-5) Cassel Research Laboratories Pvt. Ltd, Chennai 600 044, India. Cracked, melted or sticking of tablets, presence of brown patches To discontinue packs with defective tablets
11. Loratadine Dispersible Tablets 10mg (LORIDIN RAPITAB) Cadila Healthcare Ltd, Gao – 403 401, India. Discolouration of tablets and easily breakable To discontinue packs with defective tablets
12. Meropenam Injection 1g Marksans Pharma Failure in tests for assay and uniformity of weight To withdraw batch 1121621 from market
13. Methylprednisolone acetate Injection 40mg Star Drugs & Research Labs Ltd, Hosur – 635 109, India. Clogging of needle when drawing suspension to syringe To withdraw batch 11013301 from use
14. Olanzapine Tablets 10mg The Madras Pharmaceuticals, Chennai 600 096, India. Colour variations from manufacturer’s description To withhold batch M110332 from use as a preliminary precaution
15. Paracetamol Tablets 500mg Laborate Pharmaceuticals Ltd, Nariwala, India. Failure in the test for uniformity of weight To withhold batch BPOT007 from use as a preliminary precaution
16. Sodium valproate Tablets 200mg Stallion Laboratories, India. Presence of empty blisters in intact metal strips To withhold batch S-08 from use as a preliminary precaution

Quality Defects in Pharmaceuticals Reported During the month of May 2012

No. Product Manufacturer Reason Decision
01. Carbimazole Tablets 5mg Elysium Pharmaceuticals Ltd, Vadodara, India. Failure in tests for assay, thiamazole and other related substances To withdraw batches CB1002 and CB1005
02. Chlorpheniramine Tablets 4mg MSJ Industries (Ceylon) (Pvt) Ltd, Sri Lanka. Failure in the test for related substances To withdraw batches 110102 and 110410
03. Compound Sodium Lactate Intravenous Infusion, 500ml Fresinius Kabi India Pvt Ltd, Pune, 412 220, India. Incomplete fusion of caps to the container To withhold batch from use 82EC117012 as a preliminary precaution
04. Hydroxyethyl Starch 6% Intravenous Infusion, 500ml Claris Lifesciences Ltd, Ahmedabad, India. Presence of white floating particles in intact bottles, leakage through heat seal in one bottle To withdraw batches A69C361 and A61C146
05. Levenogestrel 0.15mg & Ethinylestradiol 0.03mg Tablets with Ferrous fumerate Tablets 75mg (ORALCON-F) Famy Care Ltd, Gujarat, India Discoloured and easily breakable tablets, cracked tablets in intact packs To withdraw batch OF740
06. Lidocaine Injection 2%, 30ml (ANASICA 2%) Ambalal Sarabhai Enterprises Ltd, Vadodara 390 023, India. Presence of a yellowish powdery substance on rubber stopper, under the metal crimped cap To withhold batch from use V-4607 as a preliminary precaution
07. Xylometazoline Hydrochloride Nasal Solution 1 in 2000, 10ml (DECON) Cadila Pharmaceuticals 1389 Ika – 387 810, India Metal screw caps have been corroded To withdraw the bottles with corroded metal screw caps

Quality Defects in Pharmaceuticals Reported During the month of April 2012

No. Product Manufacturer Reason Decision
01. Co-amoxiclav Injection 600mg (AVAM-600) AMN Life Sciences Pvt Ltd, Gujarat, India. Failure in tests for ‘water’; colour variation in content & constituted solution To withdraw batch SAH-10110
02. Ifosfamide with Mesna Injection (IFEX-M) Biochem Pharmaceutical Industries Ltd, Daman (U.T.), India. Sample does not conform to manufacturer’s ‘description’
To withdraw only the vials which show the defect & to revoke decision to withhold batch IFEXM1004
03. Levothyroxine sodium Tablets 50mcg MJ Biopharm Pvt Ltd, Navi Mumbai, India. Failure in test for ‘assay’ & ‘uniformity of dosage units’
To withdraw batch VIL180210
04. Trifluoperazine Tablets 5mg Leben Laboratories Pvt Ltd, Maharastra, India. Failure in test for ‘assay’ To withdraw batch T-120

Quality Defects in Pharmaceuticals Reported During the month of March 2012

No. Product Manufacturer Reason Decision
01. Aspirin Enteric Coated Tablets 75mg (CARVA 75) Square Pharmaceuticals Ltd, Pabna, Bangladesh Failure in tests for ‘dissolution’ To withdraw batch ALIN-18 from use
02. Benzylpenicillin for Injection 1,000,000 Units Elysium Pharmaceuticals Ltd, Gujarat, India Brown spots (similar to rust formation) on crimped metal caps; corroded metal caps To withdraw batch 0080432 from use
03. Ceftriaxone for Injection 1g Karnataka Antibiotics & Pharmaceuticals Ltd, Bangalore, India Improper sealing of metal crimp; off-white powder on rubber cap To withdraw batch 4401811 from use
04. Cloxacillin sodium for Injection 250mg Makcur Laboratories Ltd, Gujarat, India Failure in test for ‘water’ To withhold batch EP 1575 from use as a preliminary precaution
05. Cloxacillin Oral Solution 125mg/5ml (CLOXIN) Kopran Ltd, Raigad, India Content aggregated to form lumps in two bottles To withdraw bottles that show the defect
06. Gentamicin Eye/Ear drops 0.3% Laborate Pharmaceuticals (India) Ltd, Panipat, India Contents were discoloured, brown strains on screw thread & inside of the screw cap To withdraw batch 9GD101 from use
07. Hydralazine hydrochloride Injection 20mg/ml Ciron Drugs & Pharmaceuticals Pvt Ltd, Thane, India Presence of thick floating particles in intact ampoules To withdraw batch EA16310 from use
08. Hydrocortisone sodium succinate Injection 100mg (VITACORT-NS-100) Vital Healthcare Pvt Ltd, Mumbai, India Content did not dissolve completely To withdraw the product from use
09. Meropenam for Injection 500mg (MAKPENEM) Makcur Laboratories Ltd, Gujarat, India Sample does not conform to ‘constituted solution’ (powder did not dissolve completely, leaving visible residue & undissolved matter) To withdraw batch EP106S from use

Quality Defects in Pharmaceuticals Reported During the month of February 2012

No. Product Manufacturer Reason Decision
01. Ampicillin sodium for Injection 250mg (NESLIN-250) Nestor Pharmaceuticals Ltd, Faridabad, India Failure in tests for ‘assay’ and ‘water’ To withdraw batch ALIN-18 from use
02. Aspirin Tablets 300mg BDH Industries Ltd, Mumbai, India Formation of crystals, strong smell, some tablets are stuck together To withhold batch 320110 from use as a preliminary precaution
03. Cefotaxime for Injection 1g Karnataka Antibiotics & Pharmaceuticals Ltd, Bangalore, India Visible particles were observed in reconstituted vials To withdraw batch 4605611 from use
04. Cefuroxime for Injection 750mg Vivek Pharmachem (India) Ltd, Jaipur, India Presence of glass pieces in reconstituted vials, sealed vials without rubber stoppers, failure in test for ‘water’ To withdraw the product from use
05. Chlorpheniramine maleate Oral Solution, 2mg in 5ml Belco Pharma, Haryana, India Presence of piece of glass in an intact bottle To withdraw batch D-273C5 from use
06. Chlorpheniramine Tablets 4mg (SEEPEM) Nestor Pharmaceuticals Ltd, Faridabad, India Failure in test for ‘related substances’ To withhold batch CHTO-06 from use as a preliminary precaution
07. Cloxacillin Capsules 500mg State Pharmaceuticals Manufacturing Corporation, Rathmalana, Sri Lanka Melted capsules, failure in test for ‘assay’
(in batches PLG04 & PLA04)
To withdraw packs containing melted capsules
08. Dexamethasone Tablets 0.5mg Bafna Pharmaceuticals Ltd, Chennai, India Failure in test for ‘assay’ To withhold batch TE2166 from use as a preliminary precaution
09. Fluconazole Injection 2mg in ml, 100ml (EXOMAX) Claris Lifesciences Ltd, Ahmedabad, India Presence of crystal-like floating particles in intact vials To withdraw batch A600068 from use
10. Fluphenazine deconate Injection 25mg in 1ml Troikaa Pharmaceuticals Ltd, Gujarat, India Samples do not conform to manufacturer’s description (colour of solution changed from pale yellow to light yellow/dark brown) To withdraw batch F 04129 from use
11. Glucose Injection 50%, 50ml Nirma Ltd, Gujarat, India Presence of black floating particles in some intact vials, defective sealing in some vials, colour variation in content among vials To withdraw batches 1071006 and 5100075 from use
12. Paracetamol Oral Suspension, 120mg in 5ml, 100ml bottle Biodeal Laboratories Pvt Ltd, Gujarat, India Samples do not conform to manufacturer’s description (change in colour of solution & formation crystalline particles) To withdraw batch 123903 from use
13. Trifluoperazine Tablets 5mg Leben Laboratories Pvt Ltd, Mumbai, India Failure in test for ‘assay’ To withhold batch T-120 from use as a preliminary precaution

Quality Failures in Pharmaceuticals Reported During the month of January 2012

No. Product Manufacturer Reason Decision
01. Aspirin Enteric Coated Tablets 75mg (CARVA 75) Square Pharmaceuticals Ltd, Pabna, Banglades. Failure in test for ‘dissolution’ To withhold batch 0080432 from use as a preliminary precaution
02. Benzylpenicillin Sterile Powder for Injection BP 1,000,000 Units Elysium Pharmaceuticals Ltd, Gujarat, India. White powdery substance on crimped metal caps of intact vials & rust formation on the crimped metal caps of some vials To withdraw batches BC1003 & BC1004 from use
03. Fluphenazine deconate Injection 25mg in 1ml Troikaa Pharmaceuticals Ltd, Gujarat, India. Samples do not conform to manufacturer’s description (colour of solution changed from pale yellow to light yellow/dark brown) To withhold batch F 04129 from use as a preliminary precaution

Quality Failures in Pharmaceuticals Reported During the month of December 2011

No. Product Manufacturer Reason Decision
01. Benzylpenicillin Injection
1,000,000 Units
Elysium Pharmaceuticals Ltd, India Rust formation on the crimped metal caps of some vials To withhold batch BC1003 from use as a preliminary precaution
02. Chlorpheniramine Tablets 4mg MSJ Industries (Ceylon) (Pvt) Ltd, Sri Lanka Failure in test for related substances To withhold batch 110102 from use as a preliminary precaution
03. Clarithromycin Injection 500mg Ciron Drugs & Pharmaceuticals Pvt Ltd, India Bases of some glass vials had detached To withdraw the product from use
04. Co-amoxiclav Injection 600mg Karnataka antibiotics & Pharmaceuticals Ltd, India Colour variation on the content among vials. Turbid and discoloured when reconstituted (some vials) To withhold batch 3300211 from use as a preliminary precaution
05. Famotidine Tablets 20mg Laborate Pharmaceuticals India Ltd, India Presence of white specs on tablets in intact packs To withdraw batches LBFT-009 and LBFT-011
06. Ibuprofen Tablets 200mg Nestor Pharmaceuticals Ltd, India Presence of white powdery substance on surface of tablets in intact packs To withdraw the product from use
07. Paracetamol Oral
Suspension 120mg in 5ml, 100ml bottle
Biodeal Laboratories Pvt. Ltd, India Change of colour of suspension with formation of crystalline particles To withhold batch 123903 from use as a preliminary precaution
08. Prednisolone Tablets 5mg MSJ Industries (Ceylon) (Pvt) Ltd, Sri Lanka Failure in test for related substances To withdraw batch 100108
09. Rifampicin Capsules 150mg Macleods Pharmaceuticals Ltd, India Failure in test for dissolution To discontinue use of packs that had been exposed to moisture
10. Thiopentone Injection 1g Neon Laboratories Ltd, India Presence of a black, thread like particles in a reconstituted vial To withhold batch 173166 from use as a preliminary precaution

 

Nalidixic Acid Tablets

B.P. 500 mg

Leben Laboratories Pvt. Ltd., L-4 Phase 111 M.I.D.C.

Akola 444 104 (Maharashtra), India.

Sample does not conform to BP specifications with respect to dissolution.

Withdraw the batch

T- 12