Drug product
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.
D-837-2013
Product summary
- Event
- Event 64182
- Status
- Terminated
- Classification
- Class I
- Quantity
- 586 bottles
- Official record key
drug-enforcement:D-837-2013
Official wording
Reason: Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Code information: Lot #: 99515, Exp 09/2016
Distribution pattern: Nationwide through internet sales.
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.