EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixt...
FDA Recall #D-1130-2023 — Class II — August 17, 2023
Product Description
EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
292 bags.
Distribution
Nationwide in the USA
Code Information
Lot# 36-260047, Exp 10/3/2023. ;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated