D-1156-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 29, 2022
- Initiation Date
- June 14, 2022
- Termination Date
- April 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4941 bottles
Product Description
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Reason for Recall
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023