Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Monsel's Solution (Ferric Subsulfate) Recalled by BioDiagnostic International Due to CGMP Deviations: Products not manufactured under current good...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BioDiagnostic International directly.
Affected Products
Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08.
Quantity: 1000 boxes
Why Was This Recalled?
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About BioDiagnostic International
BioDiagnostic International has 1 total recall tracked by RecallDetector.
Related Recalls
Icosapent Ethyl Capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Tablet/Capsule specifications: Red dots inside capsule and...
Zydus Pharmaceuticals (USA) Inc · March 9, 2026
Product label: Temozolomide Capsules Recalled by Rising Pharma Holding, Inc. Due to Failed Impurities/Degradation Specifications: An out-of-specification result observed during...
Rising Pharma Holding, Inc. · March 3, 2026
Semaglutide Inj. Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report