Drug recall D-0368-2023
Product
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; 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) P2004997, P2004998, P2004999, Exp. Date 8/31/2023; P2101206, Exp. Date 1/31/2024 , P2102486, Exp. Date 4/30/2024; P2106247, P2105375, Exp. Date 7/31/2024; P2107239, P2107240, Exp. Date 10/31/2024; b) P2204222 Exp. Date 7/31/2025, P2105374 Exp. 7/31/2024, P2203449 Exp. 5/31/2025
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 312,864 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.