Why it was recalled
Superpotent Drug: Product may not meet specifications throughout shelf life.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: MJ7746, Exp 04/17
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0471-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 19, 2016
- FDA report date
- Feb 15, 2017
- Quantity
- 67,946 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0471-2017, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 75984
- Address
- 150 Signet Drive
- Code information
- Lot #: MJ7746, Exp 04/17
- Report date
- Feb 15, 2017
- Product type
- Drugs
- Recall number
- D-0471-2017
- Classification
- Class III
- Recalling firm
- Apotex Inc.
- Product quantity
- 67,946 bottles
- Termination date
- Jun 15, 2022
- Reason for recall
- Superpotent Drug: Product may not meet specifications throughout shelf life.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 19, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 9, 2017