Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablet
Check against the official notice below — it lists the full affected range.
Strides Pharma Inc. is recalling Losartan Potassium Tablets, USP, 50 mg manufactured by Vivimed Life Sciences Private Limited due to current good manufacturing practice (CGMP) deviations. The tablets were found to contain AZIDO impurity levels above acceptable limits. The recall affects 381,456 bottles distributed nationwide across multiple lot numbers with expiration dates ranging from June 2022 through January 2023.
The affected products include NDC 64380-934-05 and NDC 64380-934-08 in various lot numbers. The source document does not specify a remedy or recommended action for consumers who may have this medication.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Distribution: Nationwide Quantity: 381456 bottles Lot/code info: NDC 64380-934-05 Lot 7901146A, 7901147A, 7901148A & 7901149A, Exp Date Sep-22; Lot 7901279A, 7901280A, 7901281A, 7901282A, 7901283A & 7901284A, Exp Date Nov-22; Lot 7901359A, 7901360A & 7901361A, Exp Date Dec-22; Lot 7901362A, 7901406A, 7901407A, 7901408A & 7901409A, Exp Date Jan-23. 64380-934-08 Lot 7901008A & 7901009A, Exp Date Jun-22; Lot 7901150A & 7901151A, Exp Date Sep-22; Lot 7901285B, 7901286B, 7901287A, 7901288A, 7901289A, 7901290A, 7901291A, 7901292A, 7901293A & 7901294A, Exp Date Nov-22.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.