Multi-event May 2014 FDA Recall Drug by Brookfield Prescription Center Inc. Dba Md Custom Rx

This Multi-event Class II drug recall was voluntarily initiated by Brookfield Prescription Center Inc. Dba Md Custom Rx on May 30, 2014 for the product Drug. The FDA reported the reason for recall as incorrect/undeclared excipients. The product was distributed in WI only and the recall is currently terminated.

Reported Recall Events

D-1421-2014 TERMINATED D-1419-2014 TERMINATED D-1416-2014 TERMINATED D-1417-2014 TERMINATED D-1420-2014 TERMINATED D-1418-2014 TERMINATED

Recall Number: D-1421-2014

Reason for Recall
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Initiated
05-30-2014
Reported
07-09-2014
Quantity
8 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68616
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Brookfield Prescription Center Inc. dba MD Custom Rx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WI only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-22-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-1419-2014

Reason for Recall
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Initiated
05-30-2014
Reported
07-09-2014
Quantity
850 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68616
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Brookfield Prescription Center Inc. dba MD Custom Rx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WI only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-22-2015
Product Description About Product Description
Full technical description of the product.
HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

Batch or Lot Expiration 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

Recall Number: D-1416-2014

Reason for Recall
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Initiated
05-30-2014
Reported
07-09-2014
Quantity
6000 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68616
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Brookfield Prescription Center Inc. dba MD Custom Rx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WI only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-22-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-1417-2014

Reason for Recall
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Initiated
05-30-2014
Reported
07-09-2014
Quantity
30 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68616
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Brookfield Prescription Center Inc. dba MD Custom Rx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WI only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-22-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-1420-2014

Reason for Recall
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Initiated
05-30-2014
Reported
07-09-2014
Quantity
55 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68616
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Brookfield Prescription Center Inc. dba MD Custom Rx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WI only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-22-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration 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

Recall Number: D-1418-2014

Reason for Recall
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Initiated
05-30-2014
Reported
07-09-2014
Quantity
184 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68616
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Brookfield Prescription Center Inc. dba MD Custom Rx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WI only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-22-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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