FDA Drug Moderate Class II Terminated

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

Reported: June 29, 2022 Initiated: June 14, 2022 #D-1156-2022

Product Description

Reason for Recall

Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.

Details

Recalling Firm: Teva Pharmaceuticals USA Inc
Units Affected: 4941 bottles
Distribution: Nationwide in the U.S.
Location: Parsippany, NJ

Frequently Asked Questions

What product was recalled? ▼

Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 4941 bottles.

Why was this product recalled? ▼

Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on June 29, 2022. Severity: Moderate. Recall number: D-1156-2022.

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