Drug recall D-0972-2022
Product
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 NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots and codes
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.
Recall details
- Recalling firm
- Strides Pharma Inc., East Brunswick, NJ
- Quantity
- 200407 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