Recalls / Class II
Class IID-0520-2022
Product
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
- Affected lot / code info
- Lot #: 100022970, Exp. 08/2022
Why it was recalled
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 1,175 Bottles
- Distribution pattern
- nationwide in the USA
Timeline
- Recall initiated
- 2022-01-10
- FDA classified
- 2022-02-02
- Posted by FDA
- 2022-02-09
- Terminated
- 2022-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0520-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.