Recalls / Class II
Class IID-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
- Brand name
- Losartan Potassium
- Generic name
- Losartan Potassium
- Active ingredient
- Losartan Potassium
- Route
- Oral
- NDCs
- 64380-933, 64380-934, 64380-935
- FDA application
- ANDA090382
- Affected 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.
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm
- Firm
- Strides Pharma Inc.
- Manufacturer
- Strides Pharma Science Limited
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1102, N/A, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 381456 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2022-05-18
- FDA classified
- 2022-05-28
- Posted by FDA
- 2022-06-08
- Terminated
- 2023-10-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0973-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.