Drug recall D-0973-2022
Product
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 tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots and codes
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.
Recall details
- Recalling firm
- Strides Pharma Inc., East Brunswick, NJ
- Quantity
- 381456 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 18, 2022
- Terminated
- October 20, 2023
Related products
- Losartan potassium – drug information
- NDC 64380-934 LOSARTAN POTASSIUM 50 mg · Losartan Potassium 50 mg/1 · Strides Pharma Science Limited
- NDC 64380-935 LOSARTAN POTASSIUM 100 mg · Losartan Potassium 100 mg/1 · Strides Pharma Science Limited
- NDC 64380-933 LOSARTAN POTASSIUM 25 mg · Losartan Potassium 25 mg/1 · Strides Pharma Science Limited