PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL),...
FDA Recall #D-0414-2024 — Class II — November 9, 2023
Product Description
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
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
33,072 syringes; expanded 9,041 syringes
Distribution
Nationwide in the USA
Code Information
Lot #: 1223045536 Exp 12/06/23; 1223045710 Exp 12/10/23; 1223046574 Exp 01/12/24; 1223047579 Exp 02/21/24; 1223047764 Exp 03/06/24; 1223048363 Exp 03/30/24; 1223048364 Exp 03/30/24; 1223048566 Exp 04/06/24; 1223048573 Exp 04/07/24; 1223048574 Exp 04/07/24; 1223048643 Exp 04/11/24; 1223048697 Exp 04/12/24; 1223048742 Exp 04/13/24 Expanded lots#: 1223048065, Exp 04/06/2024; 1223048395, 1223048397, Exp 03/27/2024; 1223049980, Exp 06/05/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated