FDAClass IIIMay 10, 2017

Aripiprazole Tablets recall: Superpotent

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

Why was Aripiprazole Tablets recalled?

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

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: T-00601 Exp: 04-2017

Product
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
Recalling firm
The Harvard Drug Group
Quantity
36,990 tablets
Distribution
Nationwide and PR
Recall date
May 10, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls