Medgyn Recalls Monsel's Solution for Manufacturing Practice Deviations
Medgyn Products, Inc. is recalling 2,750 boxes of Monsel's Solution because the product was not manufactured under current good manufacturing practices.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves CGMP deviations without reported illnesses or injuries, which aligns with the rubric for moderate severity involving voluntary precautionary recalls or low-risk contamination.
Plain-English summary
Medgyn Products, Inc. is recalling 2,750 boxes of Monsel's Solution (Ferric Subsulfate), 20%. The product is packaged as 12 single application vials and 12 applicators, with 8 mL per box. The recall is being conducted because the manufacturer determined that the product was not manufactured under current good manufacturing practices (CGMP).
The affected product, NDC 42721-112-08, was distributed nationwide in the USA and in Barbados, Cayman Islands, Chile, Cyprus, Ecuador, El Salvador, Guatemala, Hong Kong, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Mongolia, Montenegro, Mozambique, Pakistan, Paraguay, Peru, Republic of Georgia, Serbia, South Africa, Tanzania, United Arab Emirates, Venezuela, and Vietnam. The recall includes all lots within expiry.
Consumers and healthcare providers should stop using the recalled product and contact Medgyn Products, Inc. for further instructions or a refund.
The recalled product
- Product
- 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…
- Manufacturer
- Medgyn Products, Inc.
- Category
- Drug — Topical Hemostatic
- Hazard
- Affected units
- 2,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #s: all lots within expiry
Distribution
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