Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SC...
FDA Recall #D-0207-2021 — Class II — December 17, 2020
Product Description
Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
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
5,990 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220022961, BUD 1/20/2021; 1220023121, BUD 1/25/2021; 1220023207, BUD 2/12/2021; 1220023363, BUD 2/17/2021 & 1220023526, BUD 2/23/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated