Drug product
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
D-1156-2022
Product summary
- Event
- Event 90430
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4941 bottles
- Official record key
drug-enforcement:D-1156-2022
Official wording
Reason: Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Code information: Lot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
Out of Specification