Drug product
HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
D-1419-2014
Product summary
- Event
- Event 68616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 850 tablets
- Official record key
drug-enforcement:D-1419-2014
Official wording
Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Code information: Lot # / Beyond Use Date: 05022014@5 / BUD 07/01/14; 04032014@7 / BUD 06/02/14; 04092014@16 / BUD06/08/14; 04142014@51 / BUD 06-13-14; 04152014@48 / BUD 06/14/14; 04172014@42 / BUD 06-06-14; 04182014@45 / BUD 6-17-14; 05162014@41 / BUD 07/15/14; 04172014@44 / BUD 06/16/14; 04212014@37 / BUD 6/20/14; 04222014@10 / BUD 06/21/14; 04232014@30 / BUD 06/22/14; 05072014@37 / BUD 07-06-14; 04292014@31 / BUD 06/28/14; 04302014@9 / BUD 06/29/14; 04252014@43 / BUD 06/24/14; 04222014@28 / BUD 6 -21-14
Distribution pattern: WI only
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.