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Products Recalled in 2022

S/NDate recall was initiatedProduct Name/ Product CategoryINN Name (s)Batch Number(s)Name of ManufacturerReasons for recall
524/06/2022EEATM Auto SutureTM Circular Stapler with DST SeriesTM Technology 25mm Intraluminal circular stapler AllCovidien llc 15 Hampshire Street Mansfield , USAA 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. 
424/06/2022Dawaflox DPS suspension 100MLFlucloxacillin2006121, 2012085Dawa Lifesciences LtdFailure of assay during stability studies
307/03/2022Vasofix certo G24X19MM yellowPeripheral vascular infusion catheter20A19G8334, 20A21G8381B.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.
221/02/2022ALKAR-UR effervescent granule satchetsSodium bicarbonate 1.76g, Tartaric acid 0.890g, Citric acid anhydrous 0.720g and trisodium citrate anhydrous3620100National Pharmaceutical Industries Co. (SAOC), Sultanate of OmanSachets bloated and powder agglomerated
114/01/2022Pregsmile tablets 3 *10sDoxylamine/Pyridoxine / Folic acidEKE-235Corona Remedies Pvt.Ltd, IndiaMix up (found to contain blister of Rosuvastatin)