FDAFDA · Food and drugs·Recall number D-0399-2015
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
Published March 11, 2015 · Recall initiated: February 23, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sagent Pharmaceuticals Inc
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot Numbers: VATB012, VATB013, VATB014, Exp 11/15; VATB017, Exp 08/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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