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

FDA recall notice · announced December 9, 2020 · Golden State Medical Supply

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot #: GS026353, GS027150, GS027653, GS028044, Exp. Date: 02/2021
Quantity: 11,922 bottles
Status: Terminated
Products in this recall event:
- 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 #60429-4 (D-0112-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.