BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord H...
FDA Recall #D-0375-2023 — Class II — February 7, 2023
Product Description
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.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
23,784 bottles
Distribution
United States including Puerto Rico and Canada
Code Information
Batches: P2105532, Exp. Date 6/30/2024; P2200348, Exp. Date 12/31/2024;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated