Why it was recalled
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Product description
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Lot numbers, UPCs & expiration codes
Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023
Where it was sold
USA Nationwide
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-1285-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 7, 2022
- FDA report date
- Jul 27, 2022
- Quantity
- 2010 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-1285-2022, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 90569
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023
- Postal code
- 33326-3253
- Report date
- Jul 27, 2022
- Product type
- Drugs
- Recall number
- D-1285-2022
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 2010 bottles
- Termination date
- Sep 22, 2025
- Reason for recall
- Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 21, 2022