Drug product
HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
D-1420-2014
Product summary
- Event
- Event 68616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 mL
- Official record key
drug-enforcement:D-1420-2014
Official wording
Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Code information: Lot # / Beyond Use Date: 04232014@49 / BUD 06-22-14; 04232014@2 / BUD 06/22/14; 04252014@27 / BUD 06/24/14; 04162014@33 / BUD06/15/14; 05132014@2 / BUD 07/12/14; 05092014@39 BUD 7-8-14
Distribution pattern: WI only
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.