Drug product
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
D-0431-2015
Product summary
- Firm
- Navinta LLC
- Event
- Event 70752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,628 units
- Official record key
drug-enforcement:D-0431-2015
Official wording
Reason: Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Code information: Lot #: VFMA 029, VFMA 030, VFMA 031, VFMA 032 Exp 4/15; VFMA 033, Exp 7/2016; VFMA 034, Exp 10/2017.
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility