NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, ...
FDA Recall #D-0745-2023 — Class II — April 28, 2023
Product Description
NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8097-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4994 bags
Distribution
Nationwide in the USA.
Code Information
Lot # 37-884510, Exp 05/04/2023; 37-885671, Exp 05/09/2023; 37-886285, Exp 05/11/2023; 37-888322, Exp 05/21/2023; 37-888851, Exp 05/22/2023; 37-889840, Exp 05/25/2023; 37-890130, Exp 05/28/2023; 37-890966, Exp 05/30/2023; 37-893529, Exp 06/11/2023; 37-894766, Exp 06/14/2023; 37-895300, 37-895301, Exp 06/18/2023; 37-898521, Exp 06/29/2023; 37-900338, Exp 07/06/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated