Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution.
Product description
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Lot numbers, UPCs & expiration codes
a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021
Where it was sold
Distributed 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-0106-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 11, 2020
- FDA report date
- Nov 25, 2020
- Quantity
- a)552 bottles; b) 3192 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0106-2021, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 86736
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021
- Postal code
- 33326-3253
- Report date
- Nov 25, 2020
- Product type
- Drugs
- Recall number
- D-0106-2021
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- a)552 bottles; b) 3192 bottles
- Termination date
- Aug 11, 2021
- Reason for recall
- Failed Dissolution Specifications: Out of specification for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Nov 11, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 24, 2020