D-0972-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 8, 2022
- Initiation Date
- May 18, 2022
- Termination Date
- October 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200407 bottles
Product Description
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
Distribution Pattern
Nationwide
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.