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Recall Observatory FDA recall evidence

Drug product

REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.

D-1322-2014

March 13, 2014

Class I

Product summary

Firm
Pain Free By Nature
Event
Event 67726
Status
Terminated
Classification
Class I
Quantity
7,123 bottles
Official record key
drug-enforcement:D-1322-2014

Official wording

Reason: Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.

Code information: All lots

Distribution pattern: Nationwide including Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.