drug · product 1 of 3
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
- Recall number
- D-0972-2022
- Initiated
- May 18, 2022
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Strides Pharma Inc.
- Quantity
- 200407 bottles
App-derived interpretation
AZIDO Impurity
CGMP Deviations
Inspect official wording and provenance
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Code information
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.
Distribution pattern
Nationwide