FDA-Drug2020-08-19Class 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 nationwide within the United States.
Affected count
3,932 bags
Manufactured in
755 Rainbow Rd Ste B, N/A, 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-1495-2020

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