Recalls / Class II
Class IID-1156-2022
Product
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
- Affected lot / code info
- Lot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023
Why it was recalled
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 4941 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2022-06-14
- FDA classified
- 2022-06-23
- Posted by FDA
- 2022-06-29
- Terminated
- 2023-04-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1156-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.