Class II Recall

Accord Healthcare, Inc.

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
CGMP Deviations: recalling drug products following an FDA inspection.
Classification
Class II
Status
Terminated
Lot
Batches: P2105532, Exp. Date 6/30/2024; P2200348, Exp. Date 12/31/2024;
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.