FDA-Drug2020-12-09Class II

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

Golden State Medical Supply Inc.
Hazard

FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets

Sold states
Distributed Nationwide in the USA
Affected count
11,922 bottles
Manufactured in
5187 Camino Ruiz, N/A, Camarillo, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0112-2021

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