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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- 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
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