PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 9, 2022 Initiated: January 10, 2022 #D-0520-2022

Product Description

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.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
1,175 Bottles
Distribution
nationwide in the USA
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02. Recalled by Teva Pharmaceuticals USA. Units affected: 1,175 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 February 9, 2022. Severity: Moderate. Recall number: D-0520-2022.