FDA Drug Recalls

Recalls / Class II

Class IID-1419-2014

Product

HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

Affected lot / code info
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

Why it was recalled

Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

Recalling firm

Firm
Brookfield Prescription Center Inc. dba MD Custom Rx
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
19035 W. Capitol Dr, Suite 105, Brookfield, Wisconsin 53045

Distribution

Quantity
850 tablets
Distribution pattern
WI only

Timeline

Recall initiated
2014-05-30
FDA classified
2014-07-03
Posted by FDA
2014-07-09
Terminated
2015-05-22
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1419-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls