FDAClass IIDecember 9, 2020

Aripiprazole Tablets recall: Failed Dissolution

ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS…

Why was Aripiprazole Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: GS026353, GS027150, GS027653, GS028044, Exp. Date: 02/2021

Product
ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS…
Recalling firm
Golden State Medical Supply Inc.
Quantity
11,922 bottles
Distribution
Distributed Nationwide in the USA
Recall date
December 9, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls