D-0398-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2015
- Initiation Date
- February 23, 2015
- Termination Date
- June 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 140,720 vials
Product Description
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
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 Pattern
Nationwide and Puerto Rico
Code Information
Lot Numbers: VATA012, Exp 11/15; VATA015, Exp 08/16