FDA recall D-0471-2017

Apotex Inc. · Class III · drug

Product

Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.

Reason for recall

Superpotent Drug: Product may not meet specifications throughout shelf life.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2016-12-19
Report date: 2017-02-15
Termination date: 2022-06-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Toronto, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0471-2017