The Recall Desk
ModerateFDA (Drugs)·D-0917-2018·Announced 2018-07-18

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.

What this means for you

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, C
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

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