Drug product
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
D-0576-2025
Product summary
- Event
- Event 97293
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,568 bottles
- Official record key
drug-enforcement:D-0576-2025
Official wording
Reason: Failed Dissolution Specifications: low dissolution results
Code information: Lot 23121560, Exp 4/30/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications