Drug product
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
D-0556-2026
Product summary
- Event
- Event 98874
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15,696 x 30's bottles
- Official record key
drug-enforcement:D-0556-2026
Official wording
Reason: Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Code information: Lot: 24123460, Expires: October 31, 2027.
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications