Heparin injection recalled over sterility concerns

Recall date

November 10, 2015

Source

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

Official notice title

Walgreens Infusion Services recalls Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500…

Recall number

D-0527-2016

FDA classification

Class II

Brand / firm

Walgreens Infusion Services

Sold / distributed

Texas

Why it was recalled

Lack of Assurance of Sterility

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 injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045