| 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 |
| 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 | 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 |
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| 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 |
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| 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 |