BioDiagnostic International is recalling 1,000 boxes of Monsel's Solution (Ferric Subsulfate), 20%, because the product was not manufactured in compliance with Current Good Manufacturing Practice (CGMP) requirements. This medical drug, used to stop bleeding after minor skin procedures, was packaged as 12 single-application vials and 12 applicators per box (8 mL total per box). The recall affects all lots within their expiration dates that were manufactured for MedGyn Products, Inc. and distributed nationwide.
Failure to follow good manufacturing practices means the safety, strength, and purity of the medication cannot be guaranteed, which could lead to ineffective treatment or unexpected reactions during medical procedures.
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.
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
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