Products Recalled in 2023
S/N
| Date recall was initiated | Product Name/ Product Category | INN Name (s) | Batch Number(s) | Name of Manufacturer | Reasons for recall |
17. | 15/11/2023 | Lasideal 40mg Tablets | Furosemide | 0621126 | Biodeal Laboratories Ltd | Black Spots on the tablets |
16. | 15/11/2023 | Enril 5 Tablets | Enalapril Maleate | KN532 | Prism Life Sciences LTD, India | Out Of Specification (OOS) results following routine market surveillance activities |
15. | 17/10/2023 | Beeclav 457mg Oral Suspension | Amoxicillin & Clavulanate Potassium | SEBPD-0088 | Saitech Medicare PVT LTD, India | Color change to brown after reconstitution |
14. | 18/09/2023 | Rapiclav 312.5 DT | Amoxicillin & Potassium Clavulanate | JTQ012001, JTQ012002, JTQ012003, JTQ012004, JTQ012005, JTQ012006, JTQ012007, JTQ012008, JTQ012009, JTQ012010, JTQ012011, JTQ012012, JTQ012013, JTQ012014, JTQ012015, JTQ012016, JTQ012017, JTQ012018, JTQ012019, JTQ012020 | Ipca Labroaratories LTD, India | The product |
13. | 18/09/2023 | Oralex C Mouthwash | Chlorhexedine Gluconate & Benzydamine Hydrochloride Mouth Wash | L220077 | Curis Lifesciences PVT LTD, India | Out Of Specification (OOS) results following routine market surveillance activities |
12. | 18/09/2023 | Trimoxol Oral Solution | Cotrimoxazole 240mg/5ml | 2210033; 2205033; 2210005; 2201145; 2207184 | Dawa LTD, Kenya | Bitter taste of the suspension, rendering its administration difficult for pediatric patients |
11. | 18/09/2023 | Tamedol Suspension | Paracetamol 120mg/5ml | All | Biopharma LTD, Kenya | Failure to meet prescribed market authorization requirements |
10. | 21/08/2023 | Klincord Solution | 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 |
9 | 17/08/2023 | DTO Tablets | Ofloxacin USP 200mg and Ornidazole 500mg | DDBR2201 | Coral Laboratories Ltd, India | Visible dark spots on the orange-colored tablets |
8 | 15/06/2023 | Mesporin | Ceftriaxone 500mg, 1000mg, 2000mg | Z0142Z0153, Z0030Z0129, Z0086Z0115, Z0149, Z0057, Z0107 | Labestfal Almiro Laboratories S.A., Portugal | Visible particles in reconstituted powder of the product |
7 | 01/06/2023 | Denk-Air Junior | Montelukast 4mg | 27084 | Denk Pharma GmbH & Co. KG, Germany | Out of specification result in ongoing stability study |
6 | 8/5/2023 | Normnil | Albendazole 400mg | 2103104; 2012082; 2007067; 2007098; 2006202; 2006200; | Dawa life sciences | The tablets exhibited the following issues: the appearance of mold-like dots, molding, cracking, the presence of brownish dots, and a change in color. |
5 | 3/5/2023 | Fluconazole | Fluconazole 200mg | 5810959; 5810961; 5810962; 5810960; 5811120; 5811121; 5811122; 5811123; 5811124; 5811125; 5811182; 5811183; 5811184; 5811185; 5810958; 5810959; 5810316; 5810320; 5810317; | Universal Corporation Limited | The pink tablets displayed white discoloration, while both the PVC material and unit box exhibited dark stains. |
4 | 25/4/2023 | Dopamac | Methyldopa 250mg | HMX20007A; HMX20008A; HMX20009A | Macleods pharmaceuticals Ltd | Color change, molding, tablet cracking |
3 | 3/4/2023 | Cosatrim DS | Sulfamethoxazole 800mg/Tri methoprim 160mg | 210825; 210828; | Cosmos Ltd | The tablets are fragmented and broken along the designated break lines, resulting in two or more separate pieces. |
2 | 28/03/2023 | Clindar B Capsules | 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 |
1 | 06/02/2023 | Diprofos 7mg/ml 2ML AMP MEA | 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 |