Drug product
Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
D-1416-2014
Product summary
- Event
- Event 68616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6000 mL
- Official record key
drug-enforcement:D-1416-2014
Official wording
Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Code information: Lot # / Beyond Use Date: 04282014@11 / BUD 05/28/14; 04212014@4 / BUD 05/21/2014
Distribution pattern: WI only
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.