Ephedrine Sulfate Injection recalled over sterility concerns

Recall date

August 10, 2016

Source

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

Official notice title

Allergy Laboratories, Inc. recalls Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-0…

Recall number

D-1498-2016

FDA classification

Class II

Brand / firm

Allergy Laboratories, Inc.

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.

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

What was recalled

Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.