Drug recall D-0367-2023
Product
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
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and 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;
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 539,004 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.