BioDiagnostic International Recalls Monsel's Solution for CGMP Deviations
BioDiagnostic International is recalling 1,000 boxes of Monsel's Solution (Ferric Subsulfate) 20% 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, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
BioDiagnostic International is recalling 1,000 boxes of Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box. The product is manufactured for MedGyn Products, Inc. and carries the NDC 42721-112-08. The recall covers all lots within their expiration dates.
The recall was initiated because the product was not manufactured under current good manufacturing practices (CGMP). The agency has classified this recall as Class II.
The product was distributed to one sole customer in Illinois, who further distributed the product nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their supplier or the recalling firm for instructions on return or disposal.
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
- BioDiagnostic International
- Category
- Drug — Topical Hemostatic
- Hazard
- Affected units
- 1,000
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)
- All lots within expiry
Distribution
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