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

FDA recall notice · announced May 10, 2017 · The Harvard Drug Group

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Nationwide and PR
Lot/code information: LOT: T-00601 Exp: 04-2017
Quantity: 36,990 tablets
Status: Terminated
Products in this recall event:
- 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 (D-0692-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.