Drug recall D-0375-2023
Product
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-201-01
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: P2105532, Exp. Date 6/30/2024; P2200348, Exp. Date 12/31/2024;
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 23,784 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.