Heparin Sodium 5 recalled over sterility concerns

Recall date

November 18, 2016

Source

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

Official notice title

Cantrell Drug Company recalls Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/…

Recall number

D-0193-2017

FDA classification

Class II

Brand / firm

Cantrell Drug Company

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

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 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24