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.

FDA recall notice · announced February 15, 2017 · Apotex

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

The product

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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: MJ7746, Exp 04/17
Quantity: 67,946 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0471-2017)

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