Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufac...
FDA Recall #D-0403-2023 — Class II — February 7, 2023
Product Description
Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5
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
37,691 vials
Distribution
United States including Puerto Rico and Canada
Code Information
Batches: R2101591, R2101590, R2101599, Exp. Date 11/30/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated