Drug product
LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10
D-0253-2015
Product summary
- Event
- Event 69590
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 bottles
- Official record key
drug-enforcement:D-0253-2015
Official wording
Reason: Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Code information: Lot #LJAG003, Expiry: 05/2015
Distribution pattern: U.S. Including: New York
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications