Drug product
Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60.
D-1282-2022
Product summary
- Event
- Event 90543
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 168936 bottles
- Official record key
drug-enforcement:D-1282-2022
Official wording
Reason: Failed Tablet/Capsule Specification : Capsule breakage
Code information: Lot#: 17201639, Exp 08/2022; 17201759, Exp 09/2022; 17202067, Exp 10/2022; 17210696, Exp 02/2023; 17210092, Exp 11/2022; 17210145, Exp 12/2022; 17210732, Exp 02/2023; 17211062, Exp 04/2023; 17211441, Exp 05/2023; 17211670, Exp 06/2023; 17211810, Exp 07/2023; 17211862, 17212020, 17212068, Exp 08/2023; 17212438, Exp 10/2023; 17220172, 17220251, Exp 12/2023.
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specification : Capsule breakage