Ephedrine Sulfate Injection recalled over sterility concerns

Recall date

August 24, 2016

Source

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

Official notice title

Sandoz Inc recalls Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per…

Recall number

D-1513-2016

FDA classification

Class II

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

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, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.