Drug recall D-0365-2023
Product
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC 16729-278-01, UPC 3 16729 27801 10 Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: a) P2005474, Exp 9/30/2023; P2100001, Exp 12/31/2023; P2100789, P2100790, Exp 1/31/2024; P2101319, Exp 2/28/2024; P2102147, P2102148, Exp 3/31/2024; P2104084, Exp 6/30/2024; P2105410, P2107233, P2105411, Exp 7/31/2024; P2106671, P2106673, P2106675, Exp 9/30/2024; P2200428, P2200429, P2200430, Exp 12/31/2024; P2203333, P2203334, Exp 5/31/2025; b) P2102940 Exp. 3/31/2023, P2105793, Exp. 7/31/2024;
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 747,464 bottles
- Distribution
- United States including Puerto Rico and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2023
- Terminated
- April 22, 2024
Related products
- Aripiprazole – drug information
- NDC 16729-278 Aripiprazole · Aripiprazole 2 mg/1 · Accord Healthcare, Inc.
- NDC 16729-282 Aripiprazole · Aripiprazole 20 mg/1 · Accord Healthcare, Inc.
- NDC 16729-281 Aripiprazole · Aripiprazole 15 mg/1 · Accord Healthcare, Inc.
- NDC 16729-280 Aripiprazole · Aripiprazole 10 mg/1 · Accord Healthcare, Inc.
- NDC 16729-283 Aripiprazole · Aripiprazole 30 mg/1 · Accord Healthcare, Inc.
- NDC 16729-279 Aripiprazole · Aripiprazole 5 mg/1 · Accord Healthcare, Inc.