FDA recall D-1156-2022

Product

Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, 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.

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2022-06-14

Report date

2022-06-29

Termination date

2023-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1156-2022