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Class II Recall
Teva Pharmaceuticals USA Inc
Product
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Reason
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Classification
Class II
Status
Terminated
Lot
Lot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023
Date
2022-06-29
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.