PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Sy...
FDA Recall #D-0210-2021 — Class II — December 17, 2020
Product Description
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recalling Firm
SCA Pharmaceuticals — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
14,580 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220022958, BUD 1/20/2021; 1220023013, BUD 1/18/2021; 1220023035, BUD 1/19/2021; 1220023036, BUD 1/21/2021; 1220023059, BUD 1/21/2021; 1220023094, BUD 1/25/2021; 1220023167, BUD 1/26/2021; 1220023208, BUD 1/27/2021; 1220023291, BUD 1/31/2021; 1220023359, BUD 2/2/2021; 1220023401, BUD 2/2/2021 & 1220023473, BUD 2/4/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated