Sodium Citrate 4% recalled over sterility concerns
- Recall date
- November 9, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- SCA Pharmaceuticals, LLC recalls Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by S…
- Recall number
- D-0422-2024
- FDA classification
- Class II
- Brand / firm
- SCA Pharmaceuticals, LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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