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
Reported: December 9, 2020 Initiated: November 17, 2020 #D-0112-2021
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
Details
- Recalling Firm
- Golden State Medical Supply Inc.
- Units Affected
- 11,922 bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Golden State Medical Supply Inc.. Units affected: 11,922 bottles.
Why was this product recalled? ▼
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 9, 2020. Severity: Moderate. Recall number: D-0112-2021.
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