Drug recall D-0377-2023
Product
BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-203-01, UPC 3 16729 20301 2;
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: P2105483, Exp. Date 7/31/2024;
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 10992 bottles
- Distribution
- United States including Puerto Rico and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2023
- Terminated
- April 22, 2024
Related products
- Buspirone hydrochloride – drug information
- NDC 16729-202 Buspirone Hydrochloride · Buspirone Hydrochloride 10 mg/1 · Accord Healthcare Inc.
- NDC 16729-289 Buspirone Hydrochloride · Buspirone Hydrochloride 30 mg/1 · Accord Healthcare Inc.
- NDC 16729-203 Buspirone Hydrochloride · Buspirone Hydrochloride 15 mg/1 · Accord Healthcare Inc.
- NDC 16729-201 Buspirone Hydrochloride · Buspirone Hydrochloride 7.5 mg/1 · Accord Healthcare Inc.
- NDC 16729-200 Buspirone Hydrochloride · Buspirone Hydrochloride 5 mg/1 · Accord Healthcare Inc.