ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apot...
FDA Recall #D-0112-2021 — Class II — November 17, 2020
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
Recalling Firm
Golden State Medical Supply Inc. — Camarillo, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
11,922 bottles
Distribution
Distributed Nationwide in the USA
Code Information
Lot #: GS026353, GS027150, GS027653, GS028044, Exp. Date: 02/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated