Recalls / Class II
Class IID-1418-2014
Product
HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
- Affected lot / code info
- Lot # / Beyond Use Date: 05192014@15 / BUD 07/18/14; 04142014@39 / BUD 6-13-14; 04182014@4 / BUD 6-17-14; 04162014@12 / BUD 06/15/14; 05092014@34 / BUD 07/08/14; 04162014@35 / BUD 06/15/14; 05232014@33 / BUD 07/22/14; 05022014@36 / BUD 7/1/14; 04292014@13 / BUD 06/28/14; 04282014@43 / BUD 06/27/14; 05212014@5 / BUD 07/20/14; 04292014@13 / BUD 06/28/14; 05062014@42 / BUD 07/05/14; 05022014@36 / BUD 07/01/14; 05062014@45 / BUD 07/05/14; 05082014@2 / BUD 07/07/14, 05152014@36 / BUD 7/14/14; 05212014@5 / BUD 07/20/14; 05082014@2 / BUD 07/07/14; 05132014@37 / BUD 07/12/14; 05082014@2 / BUD 07/07/14; 05132014@38 / BUD 07/12/14; 04242014@14 / BUD 6-23-14; 04162014@12 / BUD 6-15-14; 04212014@27 / BUD 6-20-14; 04292014@13 / BUD 6-28-14; 05092014@34 / BUD 7-8-14; 05212014@5 / BUD 7-20-14; 05272014@58 / BUD 7-26-14; 05222014@27 / BUD 07/21/14
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
- 184 mL
- 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-1418-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.