Drug product
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
D-1417-2014
Product summary
- Event
- Event 68616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 mL
- Official record key
drug-enforcement:D-1417-2014
Official wording
Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Code information: Lot # / Beyond Use Date: 05012014@36 / 05/15/14
Distribution pattern: WI only
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.