Drug product
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
D-0828-2020
Product summary
- Event
- Event 84818
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192 Bottles
- Official record key
drug-enforcement:D-0828-2020
Official wording
Reason: cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Code information: Lot #: 19122552, Exp 7/31/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations