PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharma...
FDA Recall #D-0961-2023 — Class II — July 14, 2023
Product Description
PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
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
8,363 bags
Distribution
Nationwide in the USA
Code Information
Lot:36-239194, 36-239195, Exp.7/10/2023; 36-240009, Exp. 7/13/2023; 36-240799, Exp.7/17/2023; 36-241147, 36-241148, Exp. 7/19/2023; 36-241740, 36-241741, Exp. 7/21/2023; 36-242562, Exp. 7/25/2023; 36-243531, Exp. 7/30/2023; 36-244886, 36-244961, Exp. 8/1/2023; 36-246713, 36-246714, 36-24671, 536-246716, Exp. 8/6/2023; 36-247344, 36-247345, 36-247347, 36-247348, 36-247349, 36-247350, Exp. 8/8/2023; 36-247823, 36-247824, 36-247825, 36-247826, Exp. 8/10/2023; 36-248356, 36-248358, Exp. 8/11/2023; 36-249226, Exp. 8/17/2023; 36-251966, Exp. 8/30/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated