Drug 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
D-0399-2015
Product summary
- Event
- Event 70600
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140,850 vials
- Official record key
drug-enforcement:D-0399-2015
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: VATB012, VATB013, VATB014, Exp 11/15; VATB017, Exp 08/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility