FDA-Drug2020-06-24Class II
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
SCA Pharmaceuticals
Hazard
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Sold states
Product was distributed to hospitals in PA and CA.
Affected count
333 bags
Manufactured in
755 Rainbow Rd Ste B, Windsor, CT, United States
Products
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1311-2020Don't want to check this manually?
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