Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Product description
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Lot numbers, UPCs & expiration codes
Batches: a)P2006421, P2004882, P2004939, P2004883, P2004940, P2004942, P2004943, P2004944, Exp. Date 8/31/2023; P2107593, P2106907, P2106906, P2106908, P2106909, Exp. Date 10/31/2024; b)P2102144, Exp. Date 3/31/2023; P2106903 Exp. Date 10/31/2023; P2204437, Exp. Date 7/31/2025;
Where it was sold
United States including Puerto Rico and Canada
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-0367-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 539,004 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0367-2023, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 91657
- Address
- 1009 Slater Rd Ste 210B
- Code information
- Batches: a)P2006421, P2004882, P2004939, P2004883, P2004940, P2004942, P2004943, P2004944, Exp. Date 8/31/2023; P2107593, P2106907, P2106906, P2106908, P2106909, Exp. Date 10/31/2024; b)P2102144, Exp. Date 3/31/2023; P2106903 Exp. Date 10/31/2023; P2204437, Exp. Date 7/31/2025;
- Postal code
- 27703-8446
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0367-2023
- Classification
- Class II
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 539,004 bottles
- Termination date
- Apr 22, 2024
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
- Distribution pattern
- United States including Puerto Rico and Canada
- Recall initiation date
- Feb 7, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 2, 2023