Drug product
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.
D-0392-2021
Product summary
- Event
- Event 87817
- Status
- Terminated
- Classification
- Class III
- Quantity
- 34296 bottles
- Official record key
drug-enforcement:D-0392-2021
Official wording
Reason: Presence of Foreign Tablet/Capsule
Code information: Batch No. 20122548, Exp Date: Aug. 2022
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet