FDAClass IIJuly 9, 2014

Mometasone 0.6 mg /60 mL Irrigation solution recall

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

Why was Mometasone 0.6 mg /60 mL Irrigation solution recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Brookfield Prescription Center Inc. dba MD Custom Rx
Quantity
6000 mL
Distribution
WI only
Recall date
July 9, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls