Sagent Pharmaceuticals Inc recalls Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Inj
Recalled March 11, 2015 · FDA recall D-0399-2015 · 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
140,850 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, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
Manufacturer(s)
Sagent Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →