EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy ...
FDA Recall #D-0954-2023 — Class II — July 14, 2023
Product Description
EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, 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. 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
9,121 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-239250, Exp. 7/10/2023; 36-240225, Exp.7/16/2023; 36-241268, 36-241270, Exp. 7/19/2023; 36-241443, Exp. 7/20/2023; 36-242436, 36-242439, Exp. 7/25/2023; 36-241443, Exp. 7/20/2023; 36-242436, 36-242439, Exp. 7/25/2023; 36-243517, 36-243738, Exp. 7/30/2023; 36-245656, Exp. 8/2/2023; 36-246154, 36-246169, 36-246672, 36-246673, 36-246674, Exp. 8/3/2023; 36-247015, 36-247016, 36-247017, Exp. 8/7/2023; 36-247339, 36-247341, 36-247342, 36-247343, Exp. 8/8/2023; 36-249466, 36-249467, Exp. 8/17/2023; 36-249591, 36-249592, Exp. 8/18/2023; 36-251338, Exp. 8/27/2023; 36-251940, Exp. 8/30/2023; 36-254371, 36-254372, 36-254373, 36-254375, Exp. 9/4/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated