Drug 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
D-0398-2015
Product summary
- Event
- Event 70600
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140,720 vials
- Official record key
drug-enforcement:D-0398-2015
Official wording
Reason: 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.
Code information: Lot Numbers: VATA012, Exp 11/15; VATA015, Exp 08/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility