FDA recall D-1285-2022

Product

Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326

Reason for recall

Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-07-07

Report date

2022-07-27

Termination date

2025-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1285-2022