drugs Class II Updated 2015-03-11

Sagent Pharmaceuticals Inc recalls Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg

Recalled 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

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: VATB012, VATB013, VATB014, Exp 11/15; VATB017, Exp 08/16
View official government recall

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