Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02

FDA recall notice · announced February 9, 2022 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, 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.

Notes

Distribution: nationwide in the USA
Lot/code information: Lot #: 100022970, Exp. 08/2022
Quantity: 1,175 Bottles
Status: Terminated
Products in this recall event:
- Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02 (D-0520-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.