Medications & Supplements/Topical Products

Cosette Pharmaceuticals, Inc.: Mometasone Furoate Topical Solution Recalled for Manufacturing Deviations

Agency Publication Date: April 9, 2021

Summary

Cosette Pharmaceuticals is voluntarily recalling approximately 15,788 bottles of Mometasone Furoate Topical Solution (0.1%), a prescription lotion used for skin conditions. This recall includes both 30 mL and 60 mL sizes distributed nationwide after manufacturing process deviations were discovered that violate Current Good Manufacturing Practice (CGMP) standards. While no specific injuries or adverse reactions have been reported, these deviations could affect the consistency or quality of the medication.

Risk

The product was manufactured using processes that did not strictly follow safety and quality regulations, which may result in a medication that does not meet its required specifications or intended quality. Failure to follow these manufacturing standards can lead to inconsistent drug performance or potential skin irritation.

What You Should Do

Check your prescription bottle for 'Mometasone Furoate Topical Solution, USP, 0.1% (Lotion)' distributed by Cosette Pharmaceuticals.
Verify the bottle size and NDC number: for 30 mL bottles, look for NDC 0713-0701-85; for 60 mL bottles, look for NDC 0713-0701-53.
Inspect the packaging for the specific affected lot numbers: for 30 mL bottles, check for lots 1014611 or 1014612 with expiration date 12/2022; for 60 mL bottles, check for lots 1014593, 1014594, or 1014595 with expiration date 10/2022.
Contact your healthcare provider or pharmacist for guidance regarding the continued use of this medication.
Return any unused product to the pharmacy or place of purchase for a refund and contact Cosette Pharmaceuticals for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Drug recall refund and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Mometasone Furoate Topical Solution, USP, 0.1% (30 mL)

Model:

NDC 0713-0701-85

Lot Numbers:

1014611 (Exp 12/2022)

1014612 (Exp 12/2022)

Date Ranges: exp 12/2022

Product: Mometasone Furoate Topical Solution, USP, 0.1% (60 mL)

Model:

NDC 0713-0701-53

Lot Numbers:

1014593 (Exp 10/2022)

1014594 (Exp 10/2022)

1014595 (Exp 10/2022)

Date Ranges: exp 10/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87608

Status: Resolved

Manufacturer: Cosette Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: a) 30 mL: 7724 b) 60 mL: 8064 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your prescription bottle for 'Mometasone Furoate Topical Solution, USP, 0.1% (Lotion)' distributed by Cosette Pharmaceuticals.

Verify the bottle size and NDC number: for 30 mL bottles, look for NDC 0713-0701-85; for 60 mL bottles, look for NDC 0713-0701-53.

Inspect the packaging for the specific affected lot numbers: for 30 mL bottles, check for lots 1014611 or 1014612 with expiration date 12/2022; for 60 mL bottles, check for lots 1014593, 1014594, or 1014595 with expiration date 10/2022.

Contact your healthcare provider or pharmacist for guidance regarding the continued use of this medication.

Return any unused product to the pharmacy or place of purchase for a refund and contact Cosette Pharmaceuticals for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Mometasone Furoate Topical Solution, USP, 0.1% (30 mL)

Model:

NDC 0713-0701-85

Lot Numbers:

1014611 (Exp 12/2022)

1014612 (Exp 12/2022)

Date Ranges: exp 12/2022

Product: Mometasone Furoate Topical Solution, USP, 0.1% (60 mL)

Model:

NDC 0713-0701-53

Lot Numbers:

1014593 (Exp 10/2022)

1014594 (Exp 10/2022)

1014595 (Exp 10/2022)

Date Ranges: exp 10/2022