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 Injec
Recalled March 11, 2015 · FDA recall D-0398-2015 · Sagent Pharmaceuticals
Hazard
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. · FDA Class II
Units
140,720 vials
Sold at
Nationwide and Puerto Rico
Description
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.
Product
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
Manufacturer(s)
Sagent Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →