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

Recall Number: D-0692-2017

Firm: The Harvard Drug Group

Classification: Class III

Status: Terminated

Report Date: 20170510

Initiation Date: 20161227

Termination Date: 20170727

Reason for Recall

Superpotent Drug; out of specification results for assay (manufacturer)

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