Cosette Mometasone Lotion Recall: CGMP Deviations Risk
Cosette Pharmaceuticals recalls 0.1% Mometasone Furoate Topical Solution lotions due to CGMP deviations. Affected products have specific NDC codes and expiration dates. Consumers should contact the company for details.
Recall notice
CGMP Deviaitons
Contact the company
What happened, in plain English
Cosette Pharmaceuticals is recalling two strengths of 0.1% Mometasone Furoate Topical Solution lotion (30mL and 60mL) because of manufacturing quality control issues. This recall is important because the product was made under conditions that don't meet regulatory standards, which could affect safety. Read more at govinfonow.com/recall/36247-cosette-mometasone-lotion-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36247-cosette-mometasone-lotion-recall-cgmp-deviations-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0327-2021
Cite this page
“Cosette Mometasone Lotion Recall: CGMP Deviations Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36247-cosette-mometasone-lotion-recall-cgmp-deviations-risk. Based on FDA recall #D-0327-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0327-2021%22&limit=1).
Why it’s dangerous
CGMP deviations refer to manufacturing quality control issues that may result in the product not meeting safety and quality standards. This could mean the lotion might not be as effective or could pose risks to users, though the exact nature of the deviation isn't specified in the recall.
Who’s affected
People who have the specific 30mL or 60mL lotions with the listed NDC codes and expiration dates are affected. Those using the product for medical purposes are most at risk due to potential quality issues.
How to tell if you have this one
Check the product label for the NDC codes 0713-0701-85 (30mL) or 0713-0701-53 (60mL). The 30mL lotions expire by December 2022 and the 60mL lotions expire by October 2022.
- Brand
Cosette Pharmaceuticals- Category
Drug
What to do — step by step
Contact Cosette Pharmaceuticals
Reach out to Cosette Pharmaceuticals directly for specific instructions on what to do with the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0327-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0327-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.