Product Safety Recalls

Product Recall Tracker

ARIPIPRAZOLE Recall D-1285-2022

Description: Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326

ARIPIPRAZOLE Recall D-1285-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1285-2022
Event ID90569
Original Package?1
Active SubstanceARIPIPRAZOLE
Drug RouteORAL
DistributionUSA Nationwide
Quantity2010 bottles
Recall ReasonFailed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Drug ClassificationClass II
Drug Code Info20220727
Product NDC60505-2673 60505-3075 60505-2674
Product NUIN0000175430
Drug UPC360505267682 360505267637
Pharma Class (EPC)Atypical Antipsychotic [EPC]
Recall Initiation Date20220707
Report Date20220727
Classification Date20220721
Address2400 N Commerce Pkwy Ste 400
Weston, FL 33326-3253
United States
Recalling FirmApotex Corp.
Initial Notification Letter
Unique Ingredient Identifier82VFR53I78
Drug Application NumberANDA078583
Structured Product Labeling (SPL ID)40ac4f7e-0729-b1f9-3951-e5bc26008e2e
Structured Product Labeling (SPL Set ID)569f1c32-fb6f-c34f-0894-4b1e7b744a8a
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