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

Recall Number: D-0207-2021

Firm: SCA Pharmaceuticals

Classification: Class II

Status: Terminated

Report Date: 20210113

Initiation Date: 20201217

Termination Date: 20211102

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

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