FDA advises health care professionals not to use MedGyn Products’ Monsel’s Solution
[6/29/2018] FDA advises health care professionals not to use any Monsel’s Solution (ferric subsulfate 20%) because the drug product was made under poor conditions. The solution is manufactured by BioDiagnostics International, Brea, California, and distributed by MedGyn Products, Inc., Addison, Illinois.
BioDiagnostics notified MedGyn of the recall of all lots of Monsel’s Solution on June 11, 2018. However, MedGyn has not yet notified its customers to remove any distributed drug product from the market.
Monsel’s Solution is used to stop bleeding after medical procedures, such as a colposcopy and a biopsy. The solution is sold in a carton containing 12 single application vials and 12 applicators, 8 mL each, NDC 42721-112-08. Health care professionals should immediately check their medical supplies, quarantine any of MedGyn’s Monsel’s Solution, and not administer it to patients.
During FDA’s recent inspection of the BioDiagnostics facility, investigators observed insanitary conditions and manufacturing practices which could result in contamination and decreased quality of the Monsel’s Solution.
To date, FDA is not aware of any reports of adverse events associated with drug products manufactured by BioDiagnostics. Patients who have received drug products manufactured by MedGyn or BioDiagnostics and have concerns should contact their health care professional.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any drug products to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.