D-0112-2021 Class II Terminated
FDA drug recall D-0112-2021 was initiated by Golden State Medical Supply Inc. on Nov 17, 2020 and is designated Class II. Reason for recall: FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets The recall status is terminated (terminated Jul 22, 2022). Affected quantity: 11,922 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 9, 2020
- Initiation Date
- Nov 17, 2020
- Termination Date
- Jul 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0112-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026