Class II · Moderate risk
Ryaltris (olopatadine hydrochloride and mometasone fluorate)
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Mometasone 0.6 mg /60 mL Irrigation solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
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
Drug: Mometasone
- Recalling firm
- Brookfield Prescription Center Inc. dba MD Custom Rx
- Origin
- WI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1416-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Mometasone recalls
See all
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
SINUVA (mometasone furoate)
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Other recalls by Brookfield Prescription Center Inc. dba MD Custom Rx
All 2014 recalls
Class II · Moderate risk
HCG (Human Chorionic Gonadotropin)
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
HCG (Human Chorionic Gonadotropin)
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
HCG 125U/Tab Tablet Tritu
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
HCG (Human Chorionic Gonadotropin)
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
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