Accord Healthcare, Inc.: Drug Recall

Recall #D-0402-2023 · 02/07/2023

Class II: Risk

Recall Details

Recall Number
D-0402-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Accord Healthcare, Inc.
Status
Terminated
Date Initiated
02/07/2023
Location
Durham, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,090 vials

Reason for Recall

CGMP Deviations: recalling drug products following an FDA inspection.

Product Description

Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton NDC 16729-465-03, UPC 3 16729 46503 8

Distribution Pattern

United States including Puerto Rico and Canada

Other Recalls by Accord Healthcare, Inc.

View all recalls by Accord Healthcare, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.