D-1156-2022 Class II Terminated
FDA drug recall D-1156-2022 was initiated by Teva Pharmaceuticals USA Inc on Jun 14, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. The recall status is terminated (terminated Apr 27, 2023). Affected quantity: 4941 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 29, 2022
- Initiation Date
- Jun 14, 2022
- Termination Date
- Apr 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1156-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026