FDA News

FDA warns physicians not to use Monsel’s solution

The FDA has uncovered that Monsel’s solution is manufactured under poor, insanitary conditions and urges health care professionals to stop using the drug product, according to an agency press release.

In a recent inspection, the FDA found that the manufacturing practices of Monsel’s solution (ferric subsulfate 20%), which is manufactured by BioDiagnostics International and distributed by MedGyn Products, could cause contamination and reduced quality of the product, according to the release.

Physicians should immediately quarantine and cease using ferric subsulfate 20%, which is used to stop bleeding after medical procedures, including colposcopy and biopsy, according to the FDA.

Disclosure: Healio Internal Medicine could not confirm relevant financial disclosures at the time of publication.

The FDA has uncovered that Monsel’s solution is manufactured under poor, insanitary conditions and urges health care professionals to stop using the drug product, according to an agency press release.

In a recent inspection, the FDA found that the manufacturing practices of Monsel’s solution (ferric subsulfate 20%), which is manufactured by BioDiagnostics International and distributed by MedGyn Products, could cause contamination and reduced quality of the product, according to the release.

Physicians should immediately quarantine and cease using ferric subsulfate 20%, which is used to stop bleeding after medical procedures, including colposcopy and biopsy, according to the FDA.

Disclosure: Healio Internal Medicine could not confirm relevant financial disclosures at the time of publication.