Mometasone Irrigation Solution Recalled for Incorrect Solvent
MD Custom Rx is recalling Mometasone irrigation solution compounded with an incorrect solvent. The product was distributed in Wisconsin.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving a labeling or formulation error without reported harm.
Plain-English summary
Brookfield Prescription Center Inc. dba MD Custom Rx is recalling Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only. The recall is due to specific drug products being compounded with an incorrect solvent, which constitutes an incorrect or undeclared excipient.
The affected product is a prescription-only medication distributed in Wisconsin. Specific lot numbers and beyond-use dates are identified in the recall notice, including 04282014@11 with a BUD of 05/28/14 and 04212014@4 with a BUD of 05/21/2014.
Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or obtain a replacement.
The recalled product
- 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
- Category
- Drug — Compounded Prescription
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # / Beyond Use Date: 04282014@11 / BUD 05/28/14
- 04212014@4 / BUD 05/21/2014
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 6 recalled by Brookfield Prescription Center Inc. dba MD Custom Rx under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Brookfield Prescription Center Inc. dba MD Custom Rx
See all →- ModerateMD Custom Rx Recalls HCG Drops Due to Incorrect Solvent
FDA (Drugs) · 2014-07-09
- ModerateFDA Recalls HCG Tablets Compounded With Incorrect Solvent
FDA (Drugs) · 2014-07-09
- ModerateMD Custom Rx Recalls Diphenhydramine Solution Due to Incorrect Solvent
FDA (Drugs) · 2014-07-09
- ModerateMD Custom Rx Recalls HCG and Methylcobalamin Drops Due to Incorrect Solvent
FDA (Drugs) · 2014-07-09
- ModerateMD Custom Rx Recalls HCG Drops Due to Incorrect Solvent
FDA (Drugs) · 2014-07-09
Same hazard · incorrect excipient
See all →- ModerateTadalafil Tablets Recalled for Incorrect Product Formulation
FDA (Drugs) · 2021-11-17
- ModerateQuVa Pharma Recalls Norepinephrine Injection Bags Due to Incorrect Excipient
FDA (Drugs) · 2018-12-19
- LowJubilant Cadista Recalls Valsartan Tablets Due to Potential Excipient Error
FDA (Drugs) · 2018-08-29
- LowJubilant Cadista Recalls Valsartan Tablets Due to Incorrect Excipient Grade
FDA (Drugs) · 2018-08-29
- ModerateJubilant Cadista Recalls Valsartan Tablets Due to Incorrect Excipient Grade
FDA (Drugs) · 2018-08-29