D-0112-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 9, 2020
- Initiation Date
- November 17, 2020
- Termination Date
- July 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,922 bottles
Product Description
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 Pattern
Distributed Nationwide in the USA
Code Information
Lot #: GS026353, GS027150, GS027653, GS028044, Exp. Date: 02/2021