SCA Pharmaceuticals recalls Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow R…

Recall date

June 16, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1311-2020

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

Product was distributed to hospitals in PA and CA.

Why it was recalled

Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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