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Medicine
 Nature of the Quality Failure  
 

Cancelation of registration certificate and Import license due to failure of registration sample to comply with BP specification with respect to the Assay test.

 

Name of the product ; Chloramphenicol capsules BP 250 mg

Manufacturer: Centurion Remedies (Pvt) Ltd, India
 

Cancelation of registration certificate and Import license due to failure of registration sample to comply with BP specification with respect to labeling. 

 

Name of the product : Chloramphenicol Ear drop BP 5% w/v

Brand name: Chlorowin

Manufacturer: Belco Pharma, India
 

Cancelation of registration certificate and Import license due to failure of registration sample to comply with BP specification with respect to Uniformity of weight.

 

Name of the product: Phenytoin Tablets BP 25 mg

Manufacturer: Mercury Laboratories Ltd, India
 

Cancelation of registration certificate and Import license due to failure of registration sample to comply with BP specification with respect to Salicylic acid test.

 

Name of the product: Aspirin tablets BP 300 mg

Manufacturer: Mercury Laboratories Ltd, India

Cancelation of registration certificate and Import license due to failure of registration sample to comply with USP specification with respect to particulate matter test.

 

Name of the product: Ceftazidime for Injection USP 500 mg

Manufacturer: Injectcare Parenterals (Pvt) Ltd, India

 

Cancelation of registration certificate and Import license due to failure of registration sample to comply with BP specification with respect to the Acidity test.

 

Name of the product: Suxamethonium Chloride Injection BP 100mg/2ml

Manufacturer: Swiss Parenterals (Pvt) Ltd, India

 

 

Recall of batch due to a quality defect.

 

Name of the product: Bisoprolol fumarate tablets USP 5mg

Brand name: BRISOTOL 5

Manufacturer: Fredun Pharmaceuticals Ltd, India

Batch No: FG9016

Failure/Defect: Some boxes/sealed packs contain less number of tablets than stated on the label of the outer carton.

 

 

Borderline Products
 Nature of the Quality Failure  

 Any available btches in the market to be withdrawn based on the recall notice published by the TGA, Australia

 

Name of the product: Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish oil, Pastilles (Soft Gummies) 60's

Manufactuer: Pharmacare Laboratories Pty Ltd, Australia

 

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    Cosmetics

       

       

     Nature of the Quality Failure  

     Hand sanitizers found to be substandard

     Recall of batch due to a Quality defect

     

    Name of the product: Rub in Hand Disinfectant (STERIMED) 

    Manufacturer: Medicom, Sri Lanka

    Batch No: SM01A20

    Failure/Defect: 1) Presence of a dead cockroach inside on bottle.

                          2) Pump bottles are not tamper-evident. Plastic wrapper seal is limited only to cap with squeezing tip 

     

     

    Details

    Recalls and Withholds - Year 2020 (Medicines)
     January 2020     
    Product Manufacturer Marketing Authorization Holder Failure NMRA recommendation Reference and date
    Warfarin Tablets BP Centurion Remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, India Yaden International (Pvt) Ltd Tablets are easily broken in to pieces when removing from the primary pack. Decision was taken by the Medicines Evaluation Committee held on 28th January 2020 Recall the product range (i.e. all strengths) NMRA/CP/P32/QF01/2020 on 14th Jan 2020
     February     
    Co-Careldopa Tablets BP 250/25mg Centurion Remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, India Yaden International (Pvt) Ltd Presence of brown/black sports on surface of tablets in intact container Withhold batch (TC-1030001) NMRA/CP/P32/QF02/2020 of 07th Feb 2020
    Vancomycin hydrochloride for Injection USP 500mg Swiss Parenterals Pvt Ltd, 809, Kerala, GIDC, Nr.Bavla, Gujarat, India PTC Medical Pvt Ltd (1) Uniformity of dosage unit (2) Some vials had parts of another label in addition to the label of the primary pack Withdraw the batch (SX-19030) NMRA/CP/P32/QF03/2020 of 7th Feb 2020
    Omeprazole for injection 40mg Not indicated Siba Holdings (Pvt) Ltd Manufacturer's name and address is not indicated on the label. Withdraw the batch(ADE-065) NMRA/CP/P32/QF04/2020 of 13th Feb 2020
    Irinotecan hydrochloride trihydrate Injection USP 1000mg/5ml Belco Pharma, 515,MIE, Bahadurgarh, Hariyana, India Pharmatec (Pvt) Ltd Particulate matter Withhold the batch(DH-I1-9) NMRA/CP/P32/QF05/2020 of 26th Feb 2020
    Cyclosporine Capsules USP 50mg Olive Healthcare, 197/2, Athiyawad, Dabhel Village,Daman-396210, (U.T), India Slim Pharmaceuticals Melted capsules in the intact blister pack Withhold the batch(C19G002) NMRA/CP/P32/QF06/2020 of 26th Feb 2020
    Paracetamol Tablets BP 500mg McCoy Pharma Pvt Ltd, S-12, MIDC, Tarapur, Dist.palghar, Maharashtra 401506, India Pharmatec (Pvt) Ltd Black patches in almost all tablets in the sealed pack submitted by the source. Withhold the batch (MP8549) NMRA/CP/P32/QF07/2020 of 26th Feb 2020
    Cephalexin for Oral Suspension USP 125mg/5ml Interpharm Pvt Ltd, Sri Lanka N/A Observation of orange colored clumps in the content of some intact bottles. Withhold the batch (47A802) NMRA/CP/P32/QF08/2020 of 26th Feb 2020
    MARCH
    Calcium Gluconate Injection BP 1g/10ml Hebei Tiancheng Pharmaceutical Co Ltd, No 18, Jinguang Street, Economic and Technological Development Zone, Cangzhou, Hebei Province, China Slim Pharmaceuticals (Pvt) Ltd Sample does not conform to BP with respect to labelling requirements
    (General requirement: label should state that the ‘preparation is free from bacterial endotoxins’ or that it ‘is apyrogenic’ and specific requirements: label should state that ‘solutions containing visible solid particles must not be used’ and ‘the name and percentage of any added stabilizing agent’)

    		 Withhold the batch
    (Batch no: 170843)

    		 NMRA/CP/P32/QF09/2020 of 10.03.2020
    Bisoprolol Fumarate USP 5mg Fredun Pharmaceutical Ltd, 14, 15, 16, Zorabian Industrial Complex, Vevoor,
    Palgar (E) – 401 401, India

    		George Steuart Health (Pvt) Ltd Some boxes/sealed packs contain lesser number of tablets than stated on the label of the outer carton Withdraw the batch (Batch number: FG9016) NMRA/CP/P32/QF19/2017 of 17.03.2020
    Rub-in Hand Rub Disinfectant (STERIMED) Medicom, 60/1, Park Street, Colombo 02,Sri Lanka

    		 Not applicable Dead cockroach was observed in one bottle and pump bottles are not tamper evident. Plastic wrapper seal is only limited to the cap with squeezing tip Withdraw the batch (Batch number: SM01A20) NMRA/CP/P32/QF10/2020 of 17.03.2020

     

    Recalls and Withholds - Year 2019 (Medicines)
    Product Manufacturer Marketing Authorization Holder Failure NMRA recommendation Reference and date
    January
    Metformin Tablets 500mg Scottish Pharma, Maharashtra, India Alaris Lanka (Pvt.) Ltd. Failure to comply with the test for assay; some tablets were cracked in intact blisters. Withhold the batch from use (Batch No. MSL015) NMRA/CP/P32/QF39/2018
    of 24-Jan-19
    February
    Domperidone Tablets BP 10mg SPMC, Rathmalana, Sri Lanka N/A Failure to comply with the test for friability Batch recall (Batch No. DOT18001) NMRA/CP/P32/QF28/2018 of 11-Feb-19
    Cefuroxime for Injection USP 750mg (THEOROXIME 750) Theon Pharmaceuticals Ltd, Solan (HP), India Slim Pharmaceuticals (Pvt.) Ltd. Failure to comply with the tests for assay and uniformity of dosage unit Product recall NMRA/CP/P32/QF32/2017 of 11-Feb-19
    Pyridostigmine Bromide Tablets USP 60mg S. G. Pharma (Pvt.) Ltd, India The Esses Pharmacy (Pvt.) Ltd. Manufacturer/Marketing Authorization holder failed to respond to NMRA query on suitability of the product for paediatric dosing Product recall NMRA/CP/P32/QF36/2017 of 11-Feb-19
                       March    
    Benzylpenicillin for Injection BP 600mg/1MIU Karnataka Antibiotics & Pharmaceuticals Ltd, India A. Baur & Co (Pvt) Ltd Formation of clumps in intact vials Batch recall (Batch No. 0700616) NMRA/CP/P32/QF31/2017 of 11-Mar-19
    Cloxacillin sodium Capsules USP 500mg S Kant Healthcare Ltd, India CIC Lifesciences Failure to comply with the tests for water Withhold the batch from use (Batch No. DN005)
    		 NMRA/CP/P32/QF01/2019 of 11-Mar-19
    Vecuronium Injection 10mg Ciron Drugs & Pharmaceuticals Pvt Ltd, India Ceyoka (Pvt) Ltd Presence of a piece of glass in the complaint sample Batch recall (Batch No. 7EB09127 NMRA/CP/P32/QF02/2019 of 19-Mar-19
    Cefuroxime axetil Tablets 250mg AMN Life Sciences Pvt Ltd, India Pharma Associates Failure to comply with description as per manufacturer’s specifications Withhold the batches from use (Batch Nos. AMNBO71L17, AMNBO72L17) NMRA/CP/P32/QF03/2019 of 19-Mar-19
    Frusemide injection 20mg/2ml Alpha Laboratories, India Pharmace (Pvt) Ltd Suspected microbial contamination 

     

    Withhold the batches from use, (Batch Nos. FR 53, FR 55)

    		 Withhold the batches from use,NMRA/CP/P32/QF04/2019 of 27-Mar-19
          April

     

    		  
    Co-amoxiclav for injection 1.2g Protech Biosystems Pvt Ltd, India NGN Enterprises Pvt Ltd Presence of visible particles in reconstituted vials pertaining to five batches Product recall NMRA/CP/P32/QF37/2017 of 02-Apr-19
    Cefuroxime for injection 750mg Inject Care Parenterals Pvt Ltd, India Yaden International (Pvt) Ltd Presence of a piece of glass in a reconstituted vial Batch recall (Batch No. IC17176014) NMRA/CP/P32/QF18/2018 of 02-Apr-19
    Frusemide injection 20mg/2ml Alpha Laboratories, India Pharmace (Pvt) Ltd Failure to comply with test for sterility  Withhold the product from use, batch recall (Batch No. FR 53)  NMRA/CP/P32/QF04/2019 of 04-Apr-19

    1).Ceftriaxone sodium for injection 250mg

    2).Ceftriaxone sodium for injection 1g

    3).Clindamycin injection 300mg

    4).Gentamicin injection 80mg

    5).Lidocaine injection 2%

    		 Alpha Laboratories, India Pharmace (Pvt) Ltd Failure to comply with test for sterility in Frusemide injection Withhold from use all parenteral products manufactured by Alpha Laboratories, India NMRA/CP/P32/QF04/2019 of 05-Apr-19

    Metformin tablets 500mg

    		 Alvita Pharma (Pvt) Ltd, India Chamee Chemists Failure to comply with test for assay   Withhold batch from use (Batch No. MP 7010) NMRA/CP/P32/QF05/2019 of 02-Apr-19

    Meropenem for injection 1000mg

    		 Scott-Edill Advanced Research Laboratories & Education Ltd, India PTC Medical (Pvt) Ltd Presence of a piece of glass in a reconstituted vial Batch recall (Batch No. 0328Z001) NMRA/CP/P32/QF06/2019 of 08-Apr-19

    Imipenem 500mg & Cliastatin 500mg for injection

    		 Chandra Bhagat Pharma Pvt Ltd, India Pharma Associates Failure to comply with test for constituted solution  Batch recall (Batch No. 1917006A) NMRA/CP/P32/QF07/2019 of 08-Apr-19

    Labetolol hydrochloride injection 100mg/20ml

    		 Kwality Pharmaceuticals Ltd, Amritsar, India Yaden International (Pvt) Ltd Presence of visible particles in some ampoules Batch recall (Batch No. N-10802) NMRA/CP/P32/QF08/2019 of 08-Apr-19

    Cloxacillin capsules 250mg

    		 SPMC, Sri Lanka N/A Failure to comply with test for uniformity of weight Batch recall (Batch No. PUE07) NMRA/CP/P32/QF09/2019 of 17-Apr-19

     

    		     May    
    Lithium Carbonate Tablets USP 250mg Atoz Pharmaceuticals Pvt Ltd, Ambattur, Chennai, India Euro Asian Pharma Pvt Ltd Failure to comply with test for assay Withhold the batch (Batch No. SR43701) NMRA/CP/P32/QF10/2019 of 02-May-19
    Cefotaxime for Injection USP 1g Emcure Pharmaceuticals, India Emerchemie NB (Ceylon) Ltd Presence of a glass piece in a reconstituted vial. Withdraw the batch (Batch No. ELF8BB8004)) NMRA/CP/P32/QF26/2017 of 07-May-19
    Morphine Tablets BP 15mg Kwality Pharmaceuticals Ltd, Nag. Kalan, Amritsar, India Yaden International (Pvt) Ltd Brown patches on surface of some tablets in intact blisters & some blisters contained pieces of tablets Withdraw the batch (Batch No. T-7357) NMRA/CP/P32/QF11/2019 of 15-May-19
    Morphine Sulphate Controlled Release Tablets 30mg Kwality Pharmaceuticals Ltd, Nag. Kalan, Amritsar, India Yaden International (Pvt) Ltd Brown patches on surface of some tablets in intact blisters Withhold the batch (Batch No. T-7138) NMRA/CP/P32/QF12/2019 of 15-May-19
    Chloral hydrate C-IV Sigma Aldrich Chemie GmbH, Riedstr 2 D-89555, Steinheim 407329970, Germany No marketing authorization holder (Supplied by MSD on a waiver of registration) According to the label, the product is laboratory grade Product recall NMRA/CP/P32/QF13/2019 of 15-May-19
    Meropenem for injection 500mg (SPECBAC) Squre Pharmaceuticals Ltd, Bangladesh Pharmace (Pvt) Ltd Presence of glass piece inside the reconstituted vial Withdraw the batch (Batch No. 7J00234) NMRA/CP/P32/QF14/2019 of 16-May-19
    Frusemide injection BP 20mg/2ml ALPA Laboratories India Pharmace (Pvt) Ltd Failure to comply with test for sterility. Discrepancy in labeling between market samples and specimen labels in registration dossier.   Product recall NMRA/CP/P32/QF04/2019 of 27-May-19
    Azithromycin Tablets USP 500mg Getz Pharma Pvt Ltd, Pakistan Hemas Pharmaceutical (Pvt) Ltd Presence of a black hair embedded in a tablet  Withdraw the batch (Batch No. 135F46)  NMRA/CP/P32/QF15/2019 of 27-May-19
          June    
    Metformin Tablets BP 500mg Alvita Pharma Pvt Ltd, 136/B, Motinagar, Vadodara 390010, Gujarat, India Chamee Chemist Failure to comply with test for assay Withdraw the batch (Batch No. MP7010) NMRA/CP/P32/QF05/2019 of 10-June-19
    Gentamycin Sulphate Injection BP 80mg/2ml North China Pharmaceuticals Co., China Dowell International Pvt Ltd Due to reports of cluster of adverse events (severe headache, soon after injection)  Withhold batch (Batch No. 180331) NMRA/CP/P32/QF16/2019 of 14-June-19
    Lithium Carbonate Tablets USP 250mg Atoz Pharmaceuticals Pvt Ltd, Ambattur, Chennai, India Euro Asian Pharma Pvt Ltd Failure to comply with test for assay Withdraw batch (Batch No. SR43701) NMRA/CP/P32/QF10/2019 of 21-June-19
                                                                                                                         July
    Co-amoxiclav for Injection BP 1.2g (UNICLAV 1.2) Navesta Pharmaceuticals Pvt. Ltd., Sri Lanka N/A Presence of a metal nut in a reconstituted vial Withdraw the batch (Batch No. 170319AMC2) NMRA/CP/P32/QF18/2019 of 03-July-19
    Cloxacillin for Injection 250mg (CLOMAX 250) Navesta Pharmaceuticals Pvt. Ltd., Sri Lanka N/A Failure to comply with test for particulate contamination; labels of two different colours in same product Withdraw batches (Batch Nos. 191018CLXI, 060219CLXI, 050219CLXI) & withhold the product NMRA/CP/P32/QF19/2019 of 08-July-19
    Amoxicillin Capsules BP 250mg State Pharmaceuticals Manufacturing Corporation, Sri Lanka N/A Failure to comply with test for dissolution Withhold the batch (Batch No. PUG20) NMRA/CP/P32/QF20/2019 of 10-July-19
    Co-amoxiclav for Injection BP 600mg (UNICLAV 600) Navesta Pharmaceuticals Pvt. Ltd., Sri Lanka N/A Failure to comply with test for assay Withhold the batch (Batch No. 020218AMC1) NMRA/CP/P32/QF21/2019 of 11-July-19
    Meropenem for Injection USP 500mg (SPECBAC) Inject Care Parenterals Pvt Ltd, Bangladesh Yaden International (Pvt) Ltd Presence of an insect like foreign body in a reconstituted vial Withdraw the batch (Batch No. IC18264002) NMRA/CP/P32/QF23/2019 of 30-July-19
                                                                                                                      August
    Tropicamide and Phenylephrine Ophthalmic Solution Appasamy Ocular Devices (P) Ltd, Puducherry, India George Steuart Health (Pvt) Ltd  Does not conform to manufacturer’s description (colour of the solution changed from colourless to light brown) Withhold the batch (Batch No. AA-091) NMRA/CP/P32/QF22/2019 of 05-August-19
    Dobutamine Injection USP 250mg/20ml Mercury Laboratories Ltd, Vadodara, Gujarat, India Yaden International (Pvt) Ltd Different colours of the solution in different vials of the same batch Withhold the batch (Batch No. 19364802) NMRA/CP/P32/QF24/2019 of 05-August-19
    Glucose Intravenous Infusion BP 50% w/v, 50ml AMN Life Sciences Pvt Ltd, Ahmedabad, Gujarat, India Pharma Associates Presence of black/brown particles on the surface of intact ampoules Withdraw the batches (Batch Nos. GLU/19/009, GLU/19/010, GLU/19/011) NMRA/CP/P32/QF25/2019 of 28-August-19
                                                                                                                     September
    Morphine sulfate Controlled Release Tablets 15mg Kwality Pharmaceuticals Ltd, Nag Kalan, Majitha Road, Amritsar, India Yaden International (Pvt) Ltd Presence of black patches on surface of some tablets. Intact blisters with empty or pockets containing partial tablets. Withdraw batch (Batch No. T- 7365) NMRA/CP/P32/QF26/2019 of 02-September-19
    Ceftriaxone for Injection USP 500mg (ALCEF -500) Alpha Laboratories Ltd, 33/2, A. B. Road, Pigdamber – 453 446, India Pharmace (Pvt) Ltd Name and address of the manufacturer not labeled. Labeling and pack not conforming to USP specifications and documents submitted with the application Withdraw batch (Batch No. CX07) NMRA/CP/P32/QF27/2019 of 09- September -19
    Co-amoxiclav for Injection BP 1.2g (UNICLAV 1.2) Navesta Pharmaceuticals Pvt Ltd, Sri Lanka N/A Failure in test for assay Withhold batch (Batch No. 440718AMC2) NMRA/CP/P32/QF18/2019 of 09- September -19
    Glucose Intravenous Infusion BP 50% w/v, 50ml AMN Life Sciences Pvt Ltd, Ahmedabad, Gujarat, India Pharma Associates Presence of black/brown particles on the surface of intact ampoules Product recall NMRA/CP/P32/QF25/2019 of 09- September -19
                                                                                                                      October
    Meropenem for Injection USP 500mg Inject Care Parenterals Pvt Ltd, Plot No 130, Silvassa Road, GIDC, Vapi –
    396 195, India

    		 Yaden International (Pvt) Ltd Failure in test for uniformity of dosage unit Withhold batch (Batch No. IC18264010) NMRA/CP/P32/QF23/2019 of 01st Oct 2019
    Iron, Minerals and Vitamins soft gelatin capsule Cadila Healthcare Limited, Plot No.417.419, 420, Sarkhej-Bavla               N.H. No. 8A, Village-Moraiya, Tal.Sanand, Dist: Ahmedabad –
    382 210, India

    		 Hemas Pharmaceuticals (Pvt) Ltd Failure in test for microbial limits Withdraw batch
    (Batch No. M812434)

    		 NMRA/CP/P32/QF29/2019 of 23rd Oct 2019
                                                                                                               November      
    Iron Sucrose Injection USP 100mg/5ml United Biotech (P) Limited, Bagbania, Baddi-Nalagarh Rd, India Klintas (Pvt) Ltd Failure to comply with the test for PH Withhold the batch(Batch no: IRIF8B2) NMRA/CP/P32/QF30/2019 of 5th Nov 2019
    Cefuroxime Axetil Tablets USP 250mg AMN Life Science Pvt Ltd, 150, Sahajanand Estate, Sarkhej, Ahmedabad, Gujarat, India Pharma Associate Failure to comply with specification for description of the product Withdraw the batches(Batch no: AMNB071L17 AMNB072L17) NMRA/CP/P32/QF03/2019 of 21st Nov 2019
    Gentamicin Injection BP 80mg/2ml Belco Pharma, 515, MIE, Bahadurgarh, Haryana, India Pharmatec (Pvt) Ltd Presence of visible floating particles in intact ampoules Withdraw the batch(Batch no: D-G1-1) NMRA/CP/P32/QF31/2019 of 21st Nov 2019
    Tropicamide and Phenylephrine Ophthalmic Solution Apasamy Ocular Devices (P) Ltd, Pharma Division, Vadamangalam, Puducherry-605102, India George Steuart Health (Pvt) Ltd Colour variation of the content in intact ampoules Withhold the batches(Batch no: AA-090, AA-087, AA-088) NMRA/CP/P32/QF22/2019 of 21st Nov 2019
    Glucose Intravenous Infusion BP 50% w/v AMN Life Science Pvt Ltd, 150, Sahajanand Estate, Sarkhej, Ahmedabad, Gujarat State, India Pharma Associates Presence of black/brown particles on the surfaces of all intact intravenous infusion ampoules Withdraw all batches supplied up to 20th Nov 2019 NMRA/CP/P32/QF25/2019 of 25th Nov 2019
    Morphine Sulphate controlled release tablets 30mg Kwality Pharmaceuticals Ltd, Nag. Kalan, Majitha Road, Amritsar, India Yaden International (Pvt) Ltd

    1).Presence of brown patches on surface of tablets.

    2). Cracked tablets inside intact blisters.

    		 Withdraw the batch(batch no: T-7138) NMRA/CP/P32/QF12/2019 of 28th Nov 2019
                                                                                                      December  
    Cefuroxime for Injection USP 750mg Inject Care Parenterals Pvt Ltd, Plot No 130, Silvassa Road, GIDC, Vapi 396195, India Yaden International (Pvt) Ltd Failure to comply with the test for reconstitution solution Withdraw the product NMRA/CP/P32/QF18/2018of 03rd Dec 2019
    Multivitamin Drops (Grovit) USV Pvt Ltd,At Visram & Co. Ltd, A 590/591,TTC Industrial Area,MIDC,Mahape,Navi Mumbai-400701,India Hemas Pharmaceutical (Pvt) Ltd Leakage of the content through the lid of intact bottles. Withhold the batch(Batch No. 47000264) NMRA/CP/P32/QF32/2019 of 03rd Dec 2019
    Metformin Tablets BP 500mg Sterling Lab, 57, Sipcot Industrial Complex, Hosur 635126 T.N), India Darley Butler & Co Ltd Failure to comply with the test for assay Withhold the batch(Batch No. GENT1807) NMRA/CP/P32/QF33/2019 of 03rd Dec 2019
    Metaraminol Injection BP 10mg/1ml Kwality Pharmaceuticals Ltd, Kalan, Majitha Road, Amritsar, India Yaden International (Pvt) Ltd Failure to comply with specifications with respect to product description and labelling Withdraw the batch(Batch No. N-11740) NMRA/CP/P32/QF34/2019 of 06th Dec 2019
    Isoniazid Tablets BP 100mg Mercury Laboratories Ltd, Unit No.2, Halol-Baroda Road, Jarod, Waghodia, Vadodara-391510, Gujarat, India Yaden International (Pvt) Ltd Failure to comply with the test for friability Withdraw the batch(Batch No.19192501) NMRA/CP/P32/QF35/2019 of 6th Dec 2019
    Pyrazinamide Tablets BP 500mg Mercury Laboratories Ltd, Unit No.2, Halol-Baroda Road, Jarod, Waghodia, Vadodara-391510, Gujarat, India Yaden International (Pvt) Ltd Failure to comply with the test for friability Withdraw the batch(Batch No.19192601) NMRA/CP/P32/QF36/2019 of 10th Dec 2019
    Co-amoxiclav Tablets USP 625mg Theon Pharmaceuticals Ltd, Saini Majra, Tehsil Nalagarh, Solan (HP)-174101, India Slim Pharmaceuticals Failure to comply with the test for dissolution Withhold the batch(Batch No. EBT180128) NMRA/CP/P32/QF37/2019 of 16th Dec 2019
    Metformin Tablets BP 500mg SPMC, Sri Lanka N/A Failure to comply with the test for dissolution Withhold the batch(Batch No. MTT18160) NMRA/CP/P32/QF38/2019 of 16th Dec 2019
    Flucloxacillin for Injection BP 1000mg Navesta Pharmaceuticals Pvt Ltd, 107A, Nakandala Road, Kindelpitiya, Millewa, Horana, Sri Lanka N/A (1) Capacity of the vial is insufficient to reconstitute the powder for injection as directed under the 'description for administration for intravenous injection' in the leaflet (2) label indicates that the sample is for IM/IV use. But instruction have not been given. Withdraw the batches(Batch No. 061018FLU2, 050918FLU2) NMRA/CP/P32/QF39/2019 of 26th Dec 2019
    Paracetamol Tablets BP 500mg SPMC, Sri Lanka N/A Presence of brown patches on surface of tablets Withdraw the batches(Batch No.PAT18044, PAT18046) NMRA/CP/P32/QF17/2019 of 26th Dec 2019
    Product Recalls - Year 2018 (Medicines)
    Product Manufacturer Marketing Authorization Holder Failure / Reason for recall NMRA reference Date
    Ipratropium Bromide Nebuliser Solution BP 0.025% (TROPUM) Zafa Pharmaceuticals (Pvt.) Ltd, Karachi, Pakistan Yaden International (Pvt.) Ltd Microbial contamination in one batch and discrepancy in primary packaging. Manufacturer/Marketing Authorization holder failed to respond to NMRA report NMRA/CP/P32/QF12/2018 4-Sep-18
    Ferrous Sulphate Tablets BP 200mg Healthy Life Pharma (Pvt.) Ltd, Maharashtra, India Slim Pharmaceuticals (Pvt.) Ltd. Sugar coatings of most of the tablets in intact blisters are cracked. NMRA/CP/P32/QF30/2017 4-Jun-18
    ">
    Recalls and Withholds - Year 2019 (Medical devices)
    Name of Medical Device

    Brand name

    		 Institution Manufacturer Batch/Lot No Date of Expiry Nature of Defect  Decision
    Ligator band for Esophageal N/A NHSL Shaili Endoscopy - India 615-622-200/15-16 11/1/2016 Sub standard.High risk

    BWH on 21.03.2016

    BWD on 10.01.2019/30.01.2019

     
    Auto Disable Syringe With Needle 0.05ml (27 G x 12mm) N/A   Wuxi Yushou Medical Appliance Co Ltd - China 1505012 5/1/2020 Samples are unsatisfactory due to the observation of brown stain at the needle end attached to the syringe in some sealed packs. BWH on 21.01.2019 / 29.01.2019
    Cotton Crepe Bandage (Stretched / Elastic) Softex BH-Hamburupitiya & Rhumatology & Rehabilitation Hospital - Ragama Global Surgical Products (Pvt) Ltd - Horana 12 9/1/2022 Sample does not conform to BP specification with respect to the weight per unit area test BWD on 07.01.2019
    Hydroxy Methylcellulose 2 % Sterile Viscoelastic Solution - 3ml pre filled syringes with cannula Optagel DH-Matara Popular Pharmaceuticals Ltd - Bangladesh ELM01, EIA10, ELM02 Dec 2019 & Dec 2020 Presence of brown stains on paper packing of peel pouches containing pre filled syringes BWH on 22.04.2019
    Disposable syringe 2ml/2.5ml with luer mount needle (23 G x 1”)              Dispovan Provincial Hospital - Nochchiyagama Hindustan Syringes & Medical Devices Ltd - India 3765J22 08/09/2021 Sample does not confirm to BP specification with respect  to the absorbance test.  BWD on 23.04.2019
    Cotton Crepe Bandage (Stretched / Elastic) Softex BH-Hamburupitiya & D/MSD Global Surgical Products (Pvt) Ltd - Horana 0025 April-2023 Sample does not conform to BP specification with respect to the weight per unit area test BWD on 25.04.2019
    Central Venous Catheter – Four Lumen CERTOFIX QUATTRO Not applicable  B.Braun Melsungen AG - Germany

    17C14A8551,

    16A18A8551,

    16F20A8551,

    16F29A8551,

    16K26A8551,

    17E17A8551,

    18B21A8551,

    18D11A8551,

    18E07A8551,

    18F19A8551,

    18H06A8551

    		 Not mentioned There is a plug fixed to close the lumen to avoid  accumulation of blood or fluid in the dead space between side hole and catheter tip. During the internal quality & post marketing surveillance activities found that this plug not stay in its intended position.         BWD on 07.06.2019
    Absorbable suture (Synthetic) USP  [Braided coated Poly (Glycolide –Co-L-Lactide) Polyglactin-910 , 75cm , Violet, 4-0)                           Solus 910 LRH Lotus Surgicals Pvt Ltd - India

    1701

    		 April-2022 Needles of the sutures break frequently while using.             BWD on 07.06.2019        
    Spinal Needle - Pencil point with introducer 25G x 88 mm Sujia DGH-Ampara Zhejiang Sujia Medical Device Co Ltd - China

    14100024

    		 Nov 2019 Some packs were observed with brown patches on the surface Discontinue using the packs of this batch which show the defect on 15.07.2019
    Ultrasound Gel -

    LRH

    Colombo North Teaching Hospital – Ragama

    De Soysa Hospital for Women

     

    		 Citotest - China

    160825

    		 Aug 2019

    1). Sample does not confirm BP specification for the microbial contamination test.

     

    2).Colour of the gel are different from each other even though the batch is the same.

     

    3).Name of manufacturer is not indicated on the label

    		 BWD on 25.07.2019
    Endotracheal tubes -

    NHSL - Colombo

    		 Unomedical Sdn. Bhd.- Malaysia

    622465R004 622329R012 622330R004 622331R004

    		 April 2021

    Cuff leak during post- operative ventilation needing ET tube replacement frequently

    PWH on 16.03.2017.

    Revoked PWH decision and BWD on 09.08.2019
    Ligature band for Esophageal N/A NHSL Shaili Endoscopy – India 615-622-200/15-16 Nov-16 Sub- standard. High risk BWH on 21.03.2016 BWD on 10.01.2019/30.01.2019
    Auto Disable Syringe With Needle 0.05ml (27 G x 12mm) N/A   Wuxi Yushou Medical Appliance Co Ltd – China 1505012 May-20 Samples are unsatisfactory due to the observation of brown stain at the needle end attached to the syringe in some sealed packs. BWH on 21.01.2019 / 29.01.2019
    Cotton Crepe Bandage (Stretched / Elastic) Softex BH-Hamburupitiya & Rhumatology & Rehabilitation Hospital - Ragama Global Surgical Products (Pvt) Ltd – Horana 12 Sep-22 Sample does not conform to BP specification with respect to the weight per unit area test BWD on 07.01.2019
    Hydroxy Methylcellulose 2 % Sterile Viscoelastic Solution - 3ml pre filled syringes with cannula Optagel DH-Matara Popular Pharmaceuticals Ltd – Bangladesh ELM01, EIA10, ELM02 Dec 2019 & Dec 2020 Presence of brown stains on paper packing of peel pouches containing pre filled syringes BWH on 22.04.2019
    Disposable syringe 2ml/2.5ml with luer mount needle (23 G x 1”) Dispovan Provincial Hospital – Nochchiyagama Hindustan Syringes & Medical Devices Ltd – India 3765J22 08/09/2021 Sample does not confirm to BP specification with respect to the absorbance test. BWD on 23.04.2019
    Cotton Crepe Bandage (Stretched / Elastic) Softex BH-Hamburupitiya & D/MSD Global Surgical Products (Pvt) Ltd – Horana 0025 April-2023 Sample does not conform to BP specification with respect to the weight per unit area test BWD on 25.04.2019
    Central Venous Catheter – Four Lumen CERTOFIX QUATTRO Not applicable B.Braun Melsungen AG – Germany 17C14A8551, 16A18A8551, 16F20A8551, 16F29A8551, 16K26A8551, 17E17A8551, 18B21A8551, 18D11A8551, 18E07A8551, 18F19A8551, 18H06A8551 Not mentioned There is a plug fixed to close the lumen to avoid accumulation of blood or fluid in the dead space between side hole and catheter tip. During the internal quality & post marketing surveillance activities found that this plug not stay in its intended position. BWD on 07.06.2019
    Absorbable suture (Synthetic) USP[Braided coated Poly (Glycolide –Co-L-Lactide) Polyglactin-910 , 75cm , Violet, 4-0) Solus 910 LRH Lotus Surgicals Pvt Ltd – India 1701 April-2022 Needles of the sutures break frequently while using. BWD on 07.06.2019
    Spinal Needle - Pencil point with introducer 25G x 88 mm Sujia DGH-Ampara Zhejiang Sujia Medical Device Co Ltd – China 14100024 Nov 2019 Some packs were observed with brown patches on the surface. Discontinue using the packs of this batch which show the defect on 15.07.2019 BWD on 01.10.2019
    Ultrasound Gel   LRH Colombo North Teaching Hospital – Ragama De Soysa Hospital for Women Citotest – China 160825 Aug 2019

    1. Sample does not confirm BP specification for the microbial contamination test.

    2. Colour of the gel are different from each other even though the batch is the same 3. Name of manufacturer is not indicated on the label.

    		 BWD on 25.07.2019
    Endotracheal tubes   NHSL – Colombo Unomedical Sdn. Bhd.- Malaysia 622465R004 622329R012 622330R004 622331R004 April 2021 Cuff leak during post- operative ventilation needing ET tube replacement frequently PWH on 16.03.2017
    Blood Glucose Test Strips. VivaCheck Ino Divisional Hospital – Hunuwala , Opanayaka VivaCheck Biotech (Hangzhou) Co Ltd –China For VivaCheck Laboratories Inc – USA 180082 Dec 2019 Sample is considered unsatisfactory due to labeling discrepancies between pasted labels and original label.Manufacturer not submitted clarification. BWH on 19.10.2018 BWD on 30.08.2019 Revoke BWD on 07.11.2019
    Auto Disable Syringe With Needle 0.05ml (27 G x 12mm) Yu Shou BH- Homagama Wuxi Yushou Medical Appliance Co Ltd – China 1505012 May 2020 Samples are unsatisfactory due to the observation of brown stain at the needle end attached to the syringe in some sealed packs. Manufacturer not submitted clarification. BWH on 21.01.2019 BWD on 30.08.2019
    ">
    Recalls and Withholds - Year 2018 (Medical devices)
    Name of Medical Device Brand name Institution Manufacturer Batch/Lot No Date of Expiry Nature of Defect  Decision
    Urethral Catheter Foley 2 Way Size 6FG Sterile Urocare LRH Uro Technology SDN BHD - Malaysia 14-G-11D 3/1/2019 Catheter do not retain water in the balloon BWD & replace stock with fresh batch on 07.03.2018
    Blood Glucose Test Strips VivaCheck Ino Divisional Hospital - Hunuwala,Opanayaka Vivacheck Biotech ( Hangzhou) CoLtd - China for Vivacheck Laboratories Inc - USA 180082 12/1/2019 Label was pasted on the outer pack in addition to the orignal label.Also date of manufacture & date of expiry printed on the pasted label and original label are not same BWH on 19.10.2018
    Hydrophilic IOL - Foldable OCUVA BH-Wathupitiwala VSY Biyoteknoloji Ve llac Scan A .S - Turkey Lens - 4541 & delivery system _ 528-1720 April 2018 & May 2018 Inserton was difficult BWH on 05.02.2018
     Poly Glycolic Acid Sutures I COL BH- Kamburipitiya Stericat Gutstrings Pvt Ltd-India L11-033N 11/1/2016 Needle was detached from the suture in some intact packs BWD on 07.03.2018
    Citric Acid 50% Dricarb C -50 GH-Ampara & TH-Batticaloa Hospital Manufacturing Services Sdn.Bhd - Malaysia SYN20170401 2/1/2021 Sample is not satisfactory due to the presence of black cloudy floating particles in intact Container BWD on 07.08.2018
    Disposable Syringe 3ml with needle 23G x 1 ¼ “ Hope Castle Steert Hospital for Women Jiangxi Hengte Industry Co Ltd - China 20170808 8/1/2022 Presence of brownish stains and foreign particles in some intact packs. BWD on 19.02.2018
    Auto disable syringe 0.5ml/23G x 25mm Yu Shou RDHS- Colombo, MOH - Homagama, MOH-Kahathuduwa & MOH - Ratmalana Wuxi Yushou Medical Appliance Co Ltd - China 1312010 12/1/2018 Samples unsatisfactory as the rubber parts of the piston were melted in some intact syringes BWD on 22.01.2018
    Auto disable syringe 0.5ml/23G x 25mm Yu Shou MOH - Palagala Wuxi Yushou Medical Appliance Co Ltd - China 1605012 5/1/2021 Found hair like structure in the protective plastic cap of the needle in an intact pack BWD on 06.03.2018
    Auto disable syringe 0.5ml/23G x 25mm Yu Shou RDHS - Badulla Wuxi Yushou Medical Appliance Co Ltd - China 1406005 6/1/2019 Samples unsatisfactory as the rubber parts of the piston were melted in some intact syringes BWD on 08.03.2018
    Wound care dressing (First aid dressing)   Baursplast – Medi Plaster By the marketer Baurs Life Science SRND Pharma Manufacturing Pvt Ltd – Panadura For Baurs Life Science  1 5/1/2020 Discoloration BWD on 12.01.2018
    Disinfectant for Medical Instruments & Endoscopes contains Peracetic acid 0.35%, Hydrogen Peroxide 3.15 % & Isopropanol 1.9% with additives 90ml  Scotelin NHSL, TH- Ragama, NHRD - Welisara Huniz Co Ltd – Korea ST924F6002/ST924A6002, ST924F6003/ST924A6003, ST924F6003/ST924A5015 Not mentioned Sample is unsatisfactory as “Scotelin additives” supplied with “Scotelin base”, expires before the  “Scotelin base” BWD on 15.01.2018
    Disposable Colostomy Bags  N/A TH-Jaffna Jiangxi 3L Medical Products Group Co Ltd – China  N/A N/A There is no hydrocolloid skin barrier paste. So leakage of stools is common.**The bags are not drainable.**Can be used for a shorter duration than other bags.Adhesion to skin and does not stay with the skin when stool is accumulate. PWD on 07.11.2018
    High level disinfectant and cleaning agent for medical instruments and endoscopes [Powder contains Sodium Percarbonate & Tetra Acetyl Ethylene Diamine ( TAED)] Actosed PA Powder NHSL & LRH ACTO GmbH - Germany 1711362   Sample is considered unsatisfactory as powder not dissolve completely as per instruction of the product label  BWD on 15.10.2018
    Disposable syringe 2ml/2.5ml with luer mount needle (23 G x 1”)  Dispovan Divisional Hospital - Nochiyagama Hindustan Syringes & Medical Devices Ltd - India 3764J22 9/1/2021 Sample does not confirm to BP specification with respect  to the absorbance test. BWD on 09.11.2018
    Institution
    Details

    Details
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     011-2687743
     info@nmra.gov.lk
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