Products Recalled in 2024
S/N
| Date recall was initiated | Recall Reference Number | Product Name/ Category | INN Name (s) | Batch Number (s) | Name of Manufacturer | Reasons for recall | Status |
24. | 26/09/2024 | REC/2024/025 | Amlodipine 5mg | FLD303 | Medico Remedies Pvt Ltd, India | Mislabeling. The secondary package is labelled as Flamodip-5 (Amlodipine), while the primary package is labelled as Flaminopril-5 (Enalapril) | Ongoing | |
23. | 17/09/2024 | REC/2024/023 | Carvedilol 25mg | 27374 | Artesan Pharma GmbH & Co. KG | OOS results on dissolution | Ongoing | |
22. | 09/09/2024 | REC/2024/022 | Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Nicotinamide, Calcium Pantothenate | 299, 300 | Hof Pharmaceuticals Ltd, India | Powdering/crumbling of the tablets | Ongoing | |
21. | 15/08/2024 | REC/2024/021 | Esomeprazole 40mg | SPZ-302 | Medico Remedies Limited, India | Mix-up with Donystatin Tablets blisters within some secondary packs | Ongoing | |
20. | 14/08/2024 | REC/2024/020 | Rabeprozole 20mg | ERW2203A, ERW23001C | Macleods Pharmaceuticals Limited, India | OOS results on assay | Ongoing | |
19. | 01/08/2024 | REC/2024/019 | Ephedrine Hydrochloride | 82979 | Laboratory & Allied Ltd, Kenya | OOS results on Assay | Ongoing | |
18. | 01/08/2024 | REC/2024/018 | Doxycycline 100mg | BPL 281A | Biopharma Ltd, Kenya | OOS results on Assay, Dissolution and Weight Variation | Ongoing | |
17. | 25/07/2024 | REC/2024/017 | Paracetamol 120mg/5ml | M13016 | Medivet Products Ltd, Kenya | OOS results on Assay | Ongoing | |
16. | 18/07/2024 | REC/2024/016 | Atracurium Besylate BP 10mg | V21153 | Vital Healthcare Pvt Limited, India | OOS results on Assay | Ongoing | |
15. | 08/07/2024 | REC/2024/015 | Lidocaine & Adrenaline | 762206 | Systochem Laboratories Ltd, India | Color change to brown | Closed | |
14. | 17/07/2024 | REC/2024/014 | Paracetamol 120mg/5ml | 59014 59114 59314 59414 | Njimia (K) Ltd, Kenya | Color change from Pink to brown | Closed | |
13. | 06/06/2024 | REC/2024/013 | Salbutamol, Bromhexine & Guaiphenesin | 1022035 | Biodeal Ltd, Kenya | OOS results on Assay | Ongoing | |
12. | 15/05/2024 | REC/2024/012 | Amoxicillin + Clavulanic Acid | 27608 | Denk Pharma GmbH & Co KG, Germany | Visual changes in appearance detected in an ongoing stability study | Closed | |
11. | 23/04/2024 | REC/2024/011 | Paracetamol 120mg/5ml | 2211230 | Dawa Life Sciences Ltd, Kenya | Crystallization | Closed | |
10. | 11/04/2024 | REC/2024/010 | Diphenhydramine HCL | 329304 | Johnson & Johnson (Pty), South Africa | Safety concerns due to unacceptable high levels of Diethylene glycol | Closed | |
9. | 27/03/2024 | REC/2024/009 | Sodium chloride BP, Potassium chloride BP, Trisodium citrate BP and anhydrous glucose BP | 230179, 230182 | Cosmos Limited, Kenya | Failure in description- change in colour | Closed | |
8. | 25/03/2024 | REC/2024/008 | Elemental Calcium, Elemental Phosphorus (As milk mineral concentrate), Magnesium Hydroxide BP Equivalent to Elemental Magnesium, Zinc Sulfate Monohydrate USP Equivalent to Elemental Zinc, Vitamin D3 BP | GE-13170 | Enicar Pharmaceuticals Pvt Ltd, India, | Formation of black spots in the suspension | Closed | |
7. | 25/03/2024 | REC/2024/007 | Azithromycin 200mg/5ml | GE04139 | Enicar Pharmaceuticals Pvt Ltd, India | Formation of black spots in the suspension | Closed | |
6. | 22/03/2024 | REC/2024/006 | Polygeline | HA3004 | Piramal Pharma Limited, India | Bottle leakages and damage to mono | Closed | |
5. | 13/03/2024 | REC/2024/005 | Azithromycin | BPL 149A, BPL 068A, BPL 227A | Biopharma Ltd, Kenya | Less than the required fill volume | Ongoing | |
4. | 08/02/2024 | REC/2024/004 | Amitriptyline 25mg | 81647 | Laboratory & Allied Ltd, Kenya | Capping/Lamination of the tablets | Ongoing | |
3. | 08/02/2024 | REC/2024/003 | Chlorpromazine 100mg | 82172, 82173 82174,79887 | Laboratory & Allied Ltd, Kenya | Capping/Lamination of the tablets | Ongoing | |
2. | 22/01/2024 | REC/2024/002 | Paracetamol | 2211011 | Shijiazhuang No.4 Pharmaceutical Ltd, China | Change in color to pale yellow, along with the presence of a white crystalline deposit at the vial neck or seal, suggesting a potential issue with integrity or leakage | Closed | |
1. | 20/01/2024 | REC/2024/001 | Aqueous cream | 44523DAC; 44223DAC; 34423DAC; 13823DAC, 13223DAC | Diarim Enterprises Limited, Kenya | Presence of molds | Ongoing |