D-0431-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 15, 2015
- Initiation Date
- March 9, 2015
- Termination Date
- April 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,628 units
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
Reason for Recall
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Distribution Pattern
Nationwide
Code Information
Lot #: VFMA 029, VFMA 030, VFMA 031, VFMA 032 Exp 4/15; VFMA 033, Exp 7/2016; VFMA 034, Exp 10/2017.