FDA recall D-0106-2021

Product

Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326

Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-11-11

Report date

2020-11-25

Termination date

2021-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0106-2021