FDA recall D-0520-2022

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.

Distribution

nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-01-10

Report date

2022-02-09

Termination date

2022-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0520-2022