Why it was recalled
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Product description
Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
Lot numbers, UPCs & expiration codes
Lot #: 99515, Exp 09/2016
Where it was sold
Nationwide through internet sales.
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-837-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 4, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 586 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Reumofan Plus USA
Original FDA data
Every field from FDA enforcement report D-837-2013, exactly as published.
Show all FDA fields
- City
- Springfield
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 64182
- Address
- 737 Buttonwood Dr.
- Code information
- Lot #: 99515, Exp 09/2016
- Postal code
- 19064
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-837-2013
- Classification
- Class I
- Recalling firm
- Reumofan Plus USA
- Product quantity
- 586 bottles
- Termination date
- Jan 29, 2015
- Reason for recall
- Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
- Distribution pattern
- Nationwide through internet sales.
- Recall initiation date
- Jan 4, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2013