Drug product
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
D-0520-2022
Product summary
- Event
- Event 89385
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,175 Bottles
- Official record key
drug-enforcement:D-0520-2022
Official wording
Reason: Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Code information: Lot #: 100022970, Exp. 08/2022
Distribution pattern: nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification