US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 23, 2015 (12 years ago)

Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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.

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

Recalling firm
Sagent Pharmaceuticals Inc
NDC code
25021-659-05
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0398-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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