Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Onta...
FDA Recall #D-0471-2017 — Class III — December 19, 2016
Product Description
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
Reason for Recall
Superpotent Drug: Product may not meet specifications throughout shelf life.
Recalling Firm
Apotex Inc. — Toronto, N/A
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
67,946 bottles
Distribution
Nationwide in the USA
Code Information
Lot #: MJ7746, Exp 04/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated