Products Recalled in 2023
S/N | Recall Date | Recall Ref No. | Product Name | IIN | Batch(es) | Manufaturer | Reason for recall | Status |
18. | 07/12/2023 | REC/2023/018 | Nystatin 100,000 IU/ML | 0523083, 0523084 | Biodeal Laboratories Ltd, Kenya | During routine market surveillance activities, an Out Of Specification (OOS) result of 81.7% was observed in the assay test, with the specified limits ranging from 95.0% to 120.0% of the stated amount. | Closed | |
17. | 15/11/2023 | REC/2023/017 | Furosemide | 0621126 | Biodeal Laboratories Ltd, Kenya | Black Spots on the tablets | Closed | |
16. | 15/11/2023 | REC/2023/016 | Enalapril Maleate | KN532 | Prism Life Sciences LTD, India | Out Of Specification (OOS) results following routine market surveillance activities | Closed | |
15. | 17/10/2023 | REC/2023/015 | Amoxicillin & Clavulanic acid | SEBPD-0088 | Prism Life Sciences LTD, India | Color change to brown after reconstitution | Closed | |
14. | 18/09/2023 | REC/2023/014 | Amoxicillin & Potassium Clavulanate | JTQ012001 JTQ012002 JTQ012003 JTQ012004 JTQ012005 JTQ012006 JTQ012007 JTQ012008 JTQ012009 JTQ012010 JTQ012011 JTQ012012 JTQ012013 JTQ012014 JTQ012015 JTQ012016 JTQ012017 JTQ012018 JTQ012019 JTQ012020 | IPCA laboratories, India | Color change of tablets | Closed | |
13. | 18/09/2023 | REC/2023/013 | Chlorhexedine Gluconate & Benzydamine Hydrochloride | L220077 | Curis Lifesciences PVT LTD, India | Out Of Specification (OOS) results following routine market surveillance activities | Closed | |
12. | 18/09/2023 | REC/2023/012 | Cotrimoxazole | 2210033 2205033, 2210005, 2201145, 2207184 | Dawa life sciences, Kenya | Market Complaints of bitter taste | Closed | |
11. | 18/09/2023 | REC/2023/011 | Paracetamol 120mg/5ml | All Batches | Biopharma LTD, Kenya | Failure to meet prescribed market authorization requirements | Closed | |
10. | 21/08/2023 | REC/2023/010 | Chlorhexidine Digluconate 7.1% drops | WS21136 | West Coast Pharmaceuticals, India | The assay of the active ingredient in the product may likely drop below the specifications of 95-105% based on stability data | Closed | |
9. | 17/08/2023 | REC/2023/009 | Ofloxacin/Ornidazole | DDBR2201 | Coral Lab Ltd, India | Change in color | Closed | |
8. | 15/06/2023 | REC/2023/008 | Ceftriaxone 500mg, 1000mg, 2000mg | Z0142, Z0153 ,Z0030, Z0129 Z0086, Z0115, Z0149, Z0057, Z0107 | Labestfal Almiro Laboratories S.A., Portugal | Visible particles in reconstituted powder of the product | Ongoing | |
7. | 01/06/2023 | REC/2023/007 | Montelukast 4mg | 27084 | Denk Pharma GmbH & Co. KG,Germany | Out of specification result in ongoing stability study | Closed | |
6. | 8/5/2023 | REC/2023/006 | Albendazole 400mg | 2103104 2012082 2007067 2007098 2006202 2006200 | Dawa life sciences, Kenya | The tablets exhibited the following issues: the appearance of mold-like dots, molding, cracking, the presence of brownish dots, and a change in color. | Closed | |
5. | 3/5/2023 | REC/2023/005 | Fluconazole 200mg | 5810959, 5810961, 5810962, 5810960, 5811120, 5811121, 5811122, 5811123, 5811124,5811125, 5811182, 5811183, 5811184, 5811185, 5810958, 5810959, 5810316, 5810320, 5810317 | Universal Corporation Limited, Kenya | The pink tablets displayed white discoloration, while both the PVC material and unit box exhibited dark stains. | Closed | |
4. | 25/4/2023 | REC/2023/004 | Methyldopa | HMX20007A HMX20008A HMX20009A | Macleods pharmaceuticals Ltd | Cracking of tablet coating and dark spots on the tablets | Closed | |
3. | 3/4/2023 | REC/2023/003 | Sulfamethoxazole 800mg/Trimethoprim 160mg | 210825, 210828 | Cosmos Ltd, Kenya | Cracking along the tablet score line | Closed | |
2. | 28/03/2023 | REC/2023/002 | Clindamycin 150mg | CBLOOICE-2925 CBL002CE-2640 | Wallace Pharmaceuticals Ltd | The capsules crumbled and broke due to a defect in the primary packaging, which caused them to stick to the blister pack | Closed | |
1. | 06/02/2023 | REC/2023/001 | Betamethasone Dipropionate | W005050 W012878 W015902 W020203 W025759 W030457 W032602 | Schering Plough Labo N.V. | Use of a potentially corroded component in the manufacture of the products | Closed |