Why it was recalled
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: VFMA 029, VFMA 030, VFMA 031, VFMA 032 Exp 4/15; VFMA 033, Exp 7/2016; VFMA 034, Exp 10/2017.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0431-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 9, 2015
- FDA report date
- Apr 15, 2015
- Quantity
- 14,628 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Navinta LLC
Original FDA data
Every field from FDA enforcement report D-0431-2015, exactly as published.
Show all FDA fields
- City
- Ewing
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70752
- Address
- 1499 Lower Ferry Rd
- Code information
- Lot #: VFMA 029, VFMA 030, VFMA 031, VFMA 032 Exp 4/15; VFMA 033, Exp 7/2016; VFMA 034, Exp 10/2017.
- Postal code
- 08618-1414
- Report date
- Apr 15, 2015
- Product type
- Drugs
- Recall number
- D-0431-2015
- Classification
- Class II
- Recalling firm
- Navinta LLC
- Product quantity
- 14,628 units
- Termination date
- Apr 10, 2017
- Reason for recall
- Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 9, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 3, 2015