Drug product
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).
D-0454-2025
Product summary
- Event
- Event 96898
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21 cartons
- Official record key
drug-enforcement:D-0454-2025
Official wording
Reason: cGMP deviations
Code information: Lot #: 1021950, Exp. 11/30/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
cGMP deviations