Losartan Potassium Tablets, USP 25 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 tablets
Check against the official notice below — it lists the full affected range.
Strides Pharma Inc. is recalling Losartan Potassium Tablets, USP 25 mg manufactured by Vivimed Life Sciences Private Limited due to current good manufacturing practice (CGMP) deviations. The impurity AZIDO was found at levels above acceptable limits in the recalled products. The recall affects 200,407 bottles distributed nationwide across multiple lot numbers with expiration dates ranging from June 2022 to December 2022.
The recall involves two package sizes under NDC 64380-933-05 and NDC 64380-933-08. Specific affected lots include 7901007A, 7901144A, 7901178A, 7901179A, 7901246A, 7901247A, and 7901343A for the first NDC, and lots 7901006A, 7901145A, 7901180A, and 7901181A for the second NDC. The source document does not specify a remedy or instructions for affected consumers.
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: 200407 bottles Lot/code info: NDC 64380-933-05 Lot 7901007A, Exp Date Jun-22; Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22; Lots 7901246A & 7901247A, Exp Date Oct-22; Lot 7901343A, Exp Date Dec-22. NDC 64380-933-08 Lot 7901006A, Exp Date Jun-22; Lot 7901145A & 7901180A, Exp Date Sep-22; Lot 7901181A, Exp Date Oct-22.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.