SCA Pharmaceuticals recalls Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755
Recalled January 13, 2021 · FDA recall D-0207-2021 · SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit · FDA Class II
Units
5,990 syringes
Sold at
Product was distributed to hospitals nationwide.
Description
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product
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
Manufacturer(s)
SCA Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →