FDA recall D-1322-2014

Pain Free By Nature · Class I · drug

Product

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

Reason for recall

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

Distribution

Nationwide including Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-03-13
Report date: 2014-05-21
Termination date: 2015-06-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Harper, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1322-2014