Recalls / Class II
Class IID-0789-2022
Product
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
- Affected lot / code info
- Lot: E1321O, Exp.: 5/31/2023 Lot: E2521H, Exp.: 5/31/2023 Lot: E2621F, Exp.: 5/31/2023
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets
- Distribution pattern
- Nationwide within the U.S to CA, IN and FL.
Timeline
- Recall initiated
- 2022-04-12
- FDA classified
- 2022-04-26
- Posted by FDA
- 2022-05-04
- Terminated
- 2022-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0789-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.