Atracurium Besylate Injection recalled over sterility concerns

Recall date

February 23, 2015

Source

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

Official notice title

Sagent Pharmaceuticals Inc recalls Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Inje…

Recall number

D-0398-2015

FDA classification

Class II

Brand / firm

Sagent Pharmaceuticals Inc

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product 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

Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05