Why it was recalled
CGMP Deviations: Products 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
All lots within expiry
Where it was sold
Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.
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-0874-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 11, 2018
- FDA report date
- Jun 20, 2018
- Quantity
- 1000 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BioDiagnostic International
Original FDA data
Every field from FDA enforcement report D-0874-2018, exactly as published.
Show all FDA fields
- City
- Brea
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 80277
- Address
- 555 W Lambert Rd Ste C
- Code information
- All lots within expiry
- Postal code
- 92821-3917
- Report date
- Jun 20, 2018
- Product type
- Drugs
- Recall number
- D-0874-2018
- Classification
- Class II
- Recalling firm
- BioDiagnostic International
- Product quantity
- 1000 boxes
- Termination date
- Jul 25, 2019
- Reason for recall
- CGMP Deviations: Products 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
- Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.
- Recall initiation date
- Jun 11, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2018