Class II
Terminated
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
- Company
- Sagent Pharmaceuticals Inc
- Recall Initiated
- February 23, 2015
- Posted
- March 11, 2015
- Recall Number
- D-0398-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 140,720 vials
- Firm Location
- Schaumburg, IL, United States
Reason for Recall
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot Numbers: VATA012, Exp 11/15; VATA015, Exp 08/16
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