Why it was recalled
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
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.
Lot numbers, UPCs & expiration codes
Lot #s: all lots within expiry
Where it was sold
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.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0917-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 3, 2018
- FDA report date
- Jul 18, 2018
- Quantity
- 2750 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medgyn Products, Inc.
Original FDA data
Every field from FDA enforcement report D-0917-2018, exactly as published.
Show all FDA fields
- City
- Addison
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80309
- Address
- 100 W Industrial Rd
- Code information
- Lot #s: all lots within expiry
- Postal code
- 60101-4508
- Report date
- Jul 18, 2018
- Product type
- Drugs
- Recall number
- D-0917-2018
- Classification
- Class II
- Recalling firm
- Medgyn Products, Inc.
- Product quantity
- 2750 boxes
- Termination date
- Sep 28, 2020
- Reason for recall
- CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- 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 initiation date
- Jul 3, 2018
- Center classification date
- Jul 11, 2018