PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Phar...
FDA Recall #D-0963-2023 — Class II — July 14, 2023
Product Description
PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.
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
9,432 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-240803, Exp. 7/17/2023; 36-241149, Exp. 7/19/2023; 36-241912, Exp. 7/23/2023; 36-243527, 36-243529, Exp. 7/30/2023; 36-244889, 36-244890, 36-244891, Exp. 8/1/2023; 36-246709, 36-246710, 36-246711, 36-246712, Exp. 8/6/2023; 36-247014, Exp. 8/7/2023; 36-247611, 36-247614, 36-247616, 36-247629, 36-247631, 36-247640, Exp. 8/9/2023; 36-248282, 36-248283, 36-248285, Exp. 8/13/2023; 36-249217, 36-249219, 36-249221, 36-249223, Exp. 8/17/2023; 36-251389, 36-251390, 36-251391, Exp. 8/27/2023; 36-251512, Exp. 8/28/2023; 36-251971, 36-251973, Exp. 8/30/2023; 36-252468, Exp. 9/3/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated