Monsel's Solution recall: CGMP Deviations
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.
Why was Monsel's Solution recalled?
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s: all lots within expiry
- 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, CA 92821, NDC 42721-112-08.
- Recalling firm
- Medgyn Products, Inc.
- Quantity
- 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, Serbia, South Africa, Tanzania, United Arab Emirates, Venezuela, and Vietnam.
- Recall date
- July 18, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)