Reported Apr 15, 2015 · Terminated
Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure…
Navinta LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Navinta LLC · 1499 Lower Ferry Rd · Ewing, NJ · 08618-1414
Is this the product you have?
- Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only
- Manufactured byEmcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84
- Lot codes and dates
Lot #: VFMA 029VFMA 030VFMA 031VFMA 032 Exp 4/15VFMA 033Exp 7/2016VFMA 034Exp 10/2017
- Amount recalled
- 14,628 units
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
This product could cause temporary or reversible health problems — stop using it.
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