Recalls / Class II
Class IID-0112-2021
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
- Affected lot / code info
- Lot #: GS026353, GS027150, GS027653, GS028044, Exp. Date: 02/2021
Why it was recalled
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 11,922 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-11-17
- FDA classified
- 2020-11-30
- Posted by FDA
- 2020-12-09
- Terminated
- 2022-07-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0112-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.