D-0789-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 4, 2022
- Initiation Date
- April 12, 2022
- Termination Date
- September 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets
Product Description
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Distribution Pattern
Nationwide within the U.S to CA, IN and FL.
Code Information
Lot: E1321O, Exp.: 5/31/2023 Lot: E2521H, Exp.: 5/31/2023 Lot: E2621F, Exp.: 5/31/2023