Recalls / Class II
Class IID-0369-2023
Product
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, NDC 16729-282-01, UPC 3 16729 28201 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
- Brand name
- Aripiprazole
- Generic name
- Aripiprazole
- Active ingredient
- Aripiprazole
- Route
- Oral
- NDCs
- 16729-278, 16729-279, 16729-280, 16729-281, 16729-282, 16729-283
- FDA application
- ANDA206251
- Affected lot / code info
- Batches: a) P2100787, P2100788, Exp. Date 1/31/2024; P2104736, Exp. Date 6/30/2024; P2105492, Exp. Date 8/31/2024; P2107172, P2107175, Exp. Date 10/31/2024; P2203043, Exp. Date 5/31/2025; b) P2104086 Exp. Date 6/30/2024, P2205370 Exp. 8/31/2025;
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 170,448 bottles
- Distribution pattern
- United States including Puerto Rico and Canada
Timeline
- Recall initiated
- 2023-02-07
- FDA classified
- 2023-03-02
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0369-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.