CLASS II Drug recall · Reported 9 Jul 2014 · FDA Enforcement Report
Mometasone 0.6 mg / Irrigation solution recalled
Brookfield Prescription Center is recalling Mometasone 0.6 mg / Irrigation solution, distributed in Wisconsin. The recall was initiated on 30 May 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1416-2014
- FDA event ID
- 68616
- Recalling firm
- Brookfield Prescription Center, Brookfield, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 May 2014
- FDA classified
- 3 Jul 2014
- Reported
- 9 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
Timeline
| 30 May 2014 | Recall initiated by company | |
| 3 Jul 2014 | Classified by FDA | +34 days |
| 9 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Product as listed by the FDA
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
Where it was distributed
WI only
Questions about this recall
Why was it recalled?
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Which lots are affected?
Lot # / Beyond Use Date: 04282014@11 / BUD 05/28/14; 04212014@4 / BUD 05/21/2014
Where was it sold?
WI only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 68616This product is part of a recall event; the main page for the event is Diphenhydramine (Alcohol Base) 25 mg / Solution recalled.