PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 ...
FDA Recall #D-0420-2024 — Class II — November 9, 2023
Product Description
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
SCA Pharmaceuticals, LLC — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,671 syringes, expanded 1,911 syringes
Distribution
Nationwide in the USA
Code Information
Lot #: 1223045974 Exp 12/18/23; 1223046535 Exp 01/11/24; 1223049152 Exp 05/02/24 Expanded Lot #: 1223048067, Exp 04/06/2024; 1223048792, Exp 04/17/2024.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated