EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services...
FDA Recall #D-0958-2023 — Class II — July 14, 2023
Product Description
EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
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
6,784 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-239245, Exp. 7/10/2023; 36-241047, Exp. 7/18/2023; 36-241440, 36-241441, 36-241442, Exp. 7/20/2023; 36-242432, Exp. 7/25/2023; 36-243662, Exp. 7/30/2023; 36-246152, 36-246153, 36-246158, Exp. 8/3/2023; 36-246730, 36-246731, 36-246732, Exp. 8/6/2023; 36-247332, 36-247334, 36-247337, Exp. 8/8/2023; 36-249469, Exp. 8/17/2023; 36-249589, Exp. 8/18/2023; 36-250300, Exp. 8/23/2023; 36-251335, Exp. 8/27/2023; 36-254370, Exp. 9/4/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated