D-0399-2015 Class II Terminated
FDA drug recall D-0399-2015 was initiated by Sagent Pharmaceuticals Inc on February 23, 2015 and is designated Class II. 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. The recall status is terminated (terminated June 22, 2016). Affected quantity: 140,850 vials.
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
- 140,850 vials
Product Description
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
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: VATB012, VATB013, VATB014, Exp 11/15; VATB017, Exp 08/16