phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pha...
FDA Recall #D-0962-2023 — Class II — July 14, 2023
Product Description
phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
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
1,853 bags.
Distribution
Nationwide in the USA
Code Information
Lot: 36-249691, 36-249692, Exp. 8/20/2023; 36-250052, 36-250053, Exp. 8/22/2023; 36-251062, Exp. 8/24/2023; 36-251992, Exp. 8/30/2023; 36-252467, Exp. 9/3/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated