PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, ...
FDA Recall #D-1124-2023 — Class II — August 17, 2023
Product Description
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
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
4100 syringes
Distribution
Nationwide in the USA
Code Information
Lot# 36-262312, 36-262314, 36-262311, 36-262313, Exp 10/5/2023; 36-262739, 36-262742, 36-262741, 36-262740, 36-262738, 36-262737, Exp 10/11/2023. ;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated