Brookfield Prescription Center Inc. dba MD Custom Rx: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

Agency Publication Date: July 3, 2014

Affected Products

Product: Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

Lot # / Beyond Use Date: 04282014@11 / BUD 05/28/14; 04212014@4 / BUD 05/21/2014

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

Lot # / Beyond Use Date: 05012014@36 / 05/15/14

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

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

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

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

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

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

Product: HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

Lot # / Beyond Use Date: 04302014@21 / BUD 06/29/14

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 68616

Status: Resolved

Manufacturer: Brookfield Prescription Center Inc. dba MD Custom Rx

Manufactured In: United States

Units Affected: 6 products (6000 mL; 30 mL; 184 mL; 850 tablets; 55 mL; 8 mL)

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Sources: FDA iRES · Raw API Response

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