The Recall Desk
CriticalFDA (Drugs)·D-1322-2014·Announced 2014-05-21

REUMOFAN PLUS Tablets Recalled for Undeclared Ingredients and Lack of Approval

Pain Free By Nature is recalling REUMOFAN PLUS tablets because they were marketed without FDA approval and contain undeclared diclofenac and methocarbamol.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Pain Free By Nature is recalling REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. The product is described in the source as "Previene el cancer en los huesos, Nueva presentacion el original." A total of 7,123 bottles are affected by this recall.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared diclofenac and methocarbamol. The recall covers all lots of the product.

The product was distributed nationwide, including Puerto Rico. Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
Manufacturer
Pain Free By Nature
Category
Drug — Over-the-Counter
Hazard
Affected units
7,123

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same hazard · undeclared ingredients

See all →