EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmac...
FDA Recall #D-0959-2023 — Class II — July 14, 2023
Product Description
EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1.
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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
4,570 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-240224, Exp. 7/16/2023; 36-242322, EXP. 7/24/2023; 36-242445, Exp. 7/25/2023; 36-243305, Exp. 7/27/2023; 36-243813, Exp. 7/31/2023; 36-246166, 36-246167, Exp. 8/3/2023; 36-247670, Exp. 8/9/2023; 36-248992, Exp.8/16/2023; 36-249468, Exp. 8/17/2023; 36-249590, Exp.8/18/2023; 36-251336, 36-251644, Exp. 8/27/2023; 36-251461, Exp. 8/28/2023; 36-255531, 36-255532, Exp. 9/7/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated