Products Recalled in 2022
S/N | Date recall was initiated | Product Name/ Product Category | INN Name (s) | Batch Number(s) | Name of Manufacturer | Reasons for recall |
11 | 14/12/2022 | Famcal tablets | Calcium citrate maleate with Cholecalciferol | FDF1AD3B | Indoco Remedies Limited, Industrial area, M.DI.D.C, Thane Belapur Road, Mumbai | Out of specification of results of assay testing on stability studies program at 9M time point |
10 | 13/12/2022 | Umbicare gel | Chlorhexidine Gluconate Gel 7.1% w/w | UAM1IC1B | Indoco Remedies Limited, Industrial area, M.DI.D.C, Thane Belapur Road, Mumbai | Out Of Specification results on testing of related substances |
9 | 07/12/2022 | Tenofovir Disoproxil Fumarate/ Lamivudine/ Dolutegravir (300/300/50mg) tablets | Tenofovir Disoproxil Fumarate/ Lamivudine/ Dolutegravir (300/300/50mg) tablets | Several | Universal Corporation Limited | Market complaints on Discoloration of induction seal, broken tablets and black spots on the tablets |
8 | 12/09/2022 | Biodine mouth gargle | Povidone Iodine mouth gargle | 0122081, 0122082, 0322054, 0322056 and 0322057 | Biodeal Laboratories Ltd | Market complaint on discoloration of the products and review of retained and stability samples |
7 | 01/07/2022 | Rocephin I g Injection | Ceftriaxone 1 g injection | B0752B04 | Siegfried Hameln in Germany manufactured for ROCHE | Detection of pinholes in 10 mL Water for Injection (WFI) ampoules used in Rocephin 1.000 g finished products |
6 | 24/06/2022 | EEATM Auto SutureTM Circular Stapler with DST SeriesTM Technology 25mm | Intraluminal circular stapler | All | Covidien llc 15 Hampshire Street Mansfield, USA | A complaint was received for EEATM AutosutureTM Circular Stapler with DST SeriesTM Technology (EEAXL2535) 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. Further tissue dissection and manipulation was required to recreate tissue and the gastric pouch for anastomosis. The case was completed by using another stapler. The surgical time was extended by at least 2 hours and hospitalization for 1 day. One EEAXL2535 instrument was received at Medtronic manufacturing for evaluation of the reported conditions of “Staples Did Not Deploy” and “Disengaged Staple Guide”. The staple guide was not attached to the instrument, and it was not received for evaluation. The weld witness marks were not observed at the inner area of the shell, which is an indication of improper staple guide assembly. |
5 | 24/06/2022 | Dawaflox DPS suspension 100ML | Flucloxacillin | 2006121, 2012085 | Dawa Lifesciences Ltd | Failure of assay during stability studies |
4 | 06/04/2022 | Biodopa 250mg tablets | Methyldopa | 0321077 and 0421112 | Biodeal Laboratories Ltd | Discoloration of the tablets |
3 | 07/03/2022 | Vasofix certo G24X19MM yellow | Peripheral vascular infusion catheter | 20A19G8334, 20A21G8381 | B.Braun Melsungen AG (BBMAG) | 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. |
2 | 21/02/2022 | ALKAR-UR effervescent granule satchets | Sodium bicarbonate 1.76g, Tartaric acid 0.890g, Citric acid anhydrous 0.720g and trisodium citrate anhydrous | 3620100 | National Pharmaceutical Industries Co. (SAOC), Sultanate of Oman | Sachets bloated and powder agglomerated |
1 | 14/01/2022 | Pregsmile tablets 3 *10s | Doxylamine/Pyridoxine / Folic acid | EKE-235 | Corona Remedies Pvt.Ltd, India | Mix up (found to contain blister of Rosuvastatin) |