Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto...
FDA Recall #D-0692-2017 — Class III — December 27, 2016
Product Description
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
Reason for Recall
Superpotent Drug; out of specification results for assay (manufacturer)
Recalling Firm
The Harvard Drug Group — Livonia, MI
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
36,990 tablets
Distribution
Nationwide and PR
Code Information
LOT: T-00601 Exp: 04-2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated