Heparin Sodium 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, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose Syringe, Hospital/Office Use O…

Recall number

D-0192-2017

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, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-148-16