Why it was recalled
Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
Product description
REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide including Puerto Rico
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-1322-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 13, 2014
- FDA report date
- May 21, 2014
- Quantity
- 7,123 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pain Free By Nature
Original FDA data
Every field from FDA enforcement report D-1322-2014, exactly as published.
Show all FDA fields
- City
- Harper
- State
- KS
- Status
- Terminated
- Country
- United States
- Event ID
- 67726
- Address
- 1504 Washington St
- Code information
- All lots
- Postal code
- 67058-1554
- Report date
- May 21, 2014
- Product type
- Drugs
- Recall number
- D-1322-2014
- Classification
- Class I
- Recalling firm
- Pain Free By Nature
- Product quantity
- 7,123 bottles
- Termination date
- Jun 1, 2015
- Reason for recall
- Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
- Distribution pattern
- Nationwide including Puerto Rico
- Recall initiation date
- Mar 13, 2014
- Initial firm notification
- Press Release
- Center classification date
- May 15, 2014