FDA-Drug2024-04-03Class II

Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025

SCA Pharmaceuticals, LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
9,624 syringes
Manufactured in
755 Rainbow Rd Ste B, N/A, Windsor, CT, United States
Products
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0422-2024

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