Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported July 18, 2018
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.
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Medgyn Products, Inc. recalled Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 1… - a moderate-severity action.
Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 1… was recalled by Medgyn Products, Inc. in July 18, 2018. Reason: CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current g…. Check the official notice for the remedy. Verify recall #D-0917-2018 with the FDA Drug before acting.
The recall
Medgyn Products, Inc. issued this moderate-severity FDA Drug recall-CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current g….
- Moderate
- severity level
- Class II
- classification
- July 18, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0917-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0917-2018) was formally reported on July 18, 2018, with the manufacturer initiating the action on July 3, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Medgyn Products, Inc. is listed as the recalling firm, operating out of Addison, IL. Federal records list the affected scope as 2750 boxes.
The documented reason for this recall is: CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices. Distribution data in the federal record shows the product reached: Nationwide in the USA, Barbados, Cayman Islands, Chile, Cyprus, Ecuador, El Salvador, Guatemala, Hong Kong, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Mongolia, Montenegro, Mozambique, Pakistan, Paraguay, Peru, Republ…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2750 boxes
Related Recalls
6
5 from same agency
Product description
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.
Reason for recall
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0917-2018 |
| Date reported | July 18, 2018 |
| Date initiated | July 3, 2018 |
| Recalling firm | Medgyn Products, Inc. |
| Firm location | Addison, IL |
| Affected scope | 2750 boxes |
| Distribution | Nationwide in the USA, 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, Serbi… |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0917-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medgyn Products, Inc.. Units affected: 2750 boxes.
Why was this product recalled? ▼
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 18, 2018. Severity: Moderate. Recall number: D-0917-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA, 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0917-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 18, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.