Losartan Potassium Tablets recall: Impurity Out of Spec
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
Why was Losartan Potassium Tablets recalled?
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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
- Recalling firm
- Strides Pharma Inc.
- Quantity
- 381456 bottles
- Distribution
- Nationwide
- Recall date
- June 8, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)