FDA recall D-0112-2021

Golden State Medical Supply Inc. · Class II · drug

Product

ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30

Reason for recall

FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2020-11-17
Report date: 2020-12-09
Termination date: 2022-07-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0112-2021