FDA-Drug2021-01-13Class II
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
SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Sold states
Product was distributed to hospitals nationwide.
Affected count
5,990 syringes
Manufactured in
755 Rainbow Rd Ste B, Windsor, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0207-2021Don't want to check this manually?
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