FDAFDA · Food and drugs·Recall number D-0431-2015
Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84
Published April 15, 2015 · Recall initiated: March 9, 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. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Navinta LLC
- Distributor
- Nationwide
- Lot
- Lot #: VFMA 029, VFMA 030, VFMA 031, VFMA 032 Exp 4/15; VFMA 033, Exp 7/2016; VFMA 034, Exp 10/2017.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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