Products Recalled in 2022
S/N | Recall Date | Recall Ref No. | Product Name | IIN | Batch(es) | Manufaturer | Reason for recall | Status |
11. | 14/12/2022 | REC/2022/011 | Calcium citrate maleate with Cholecalciferol | FDF1AD3B | Indoco Remedies Limited, India | Out of specification results on assay test identified during stability studies | Closed | |
10. | 13/12/2022 | REC/2022/010 | Chlorhexidine Gluconate Gel 7.1% w/w | UAM1IC1B | Indoco Remedies Limited, India | Out Of Specification results on related substances tests | Closed | |
9. | 07/12/2022 | REC/2022/009 | Tenofovir Disoproxil Fumarate/ Lamivudine/ Dolutegravir 300/300/50mg | Several | Universal Corporation Limited, Kenya | Discoloration of induction seal, broken tablets and black spots on the tablets | Closed | |
8. | 12/09/2022 | REC/2022/008 | Povidone Iodine | 0122081, 0122082, 0322054, 0322055, 0322056, 0322057 | Biodeal Laboratories Ltd, Kenya | Change of color to colorless | Closed | |
7. | 01/07/2022 | REC/2022/007 | Ceftriaxone 1g | B0752B04 | F. Hoffmann-La Roche Ltd, Kaiseraugst | Detection of pinholes in 10 mL Water for Injection (WFI) ampoules | Closed | |
6. | 24/06/2022 | REC/2022/006 | EEATM Auto SutureTM Circular Stapler with DST SeriesTM Technology 25mm | Intraluminal circular stapler | All | Covidien llc 15 Hampshire Street Mansfield, USA | A complaint was reported as “Staples Did Not Deploy”. According to the reporter, during laparoscopic procedure the circular stapler was able to fire, but the staples did not deploy when attempting to staple a small bowel segment to the gastric pouch. | Closed |
5. | 24/06/2022 | REC/2022/005 | Flucloxacillin | 2006121, 2012085 | Dawa Lifesciences Ltd | Failure of assay identified during stability studies | Closed | |
4. | 06/04/2022 | REC/2022/004 | Methyldopa 250mg | 0321077, 0421112, 0421142 | Biodeal Laboratories Ltd | Discoloration of the tablets | Closed | |
3. | 07/03/2022 | REC/2022/003 | Peripheral vascular infusion catheter | 20A19G8334, 20A21G8381 | B.Braun Melsungen AG | A defect on the injection port that may result in potentially critical clinical consequences for the patient e.g blood loss, underdosage or delay of therapy. Third party are at risk being inContact with patients fluids. | Closed | |
2. | 21/02/2022 | REC/2022/002 | Sodium Bicarbonate 1.76g, Tartaric Acid 0.890 g, Citric acid anhydrous 0.720g, Trisodium citrate anhydrous 0.630 gm | 3620100 | National Pharmaceutical Industries Co (SAOG) Muscat, Sultanate of Oman | Sachets bloated and powder agglomerated | Closed | |
1. | 14/01/2022 | REC/2022/001 | Doxylamine/ Pyridoxine/ Folic acid | EKE-235 | Corona Remedies Pvt.Ltd, India | Mix up (found to contain blisters of Rosuvastatin) | Closed |