drugs Class II Updated 2015-03-11

Sagent Pharmaceuticals Inc recalls Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg pe

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: VATA012, Exp 11/15; VATA015, Exp 08/16
View official government recall

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