March 2014 FDA Recall Drug by Pain Free By Nature
D-1322-2014 - Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
This Class I drug recall was voluntarily initiated by Pain Free By Nature on March 13, 2014 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product contains undeclared diclofenac and methocarbamol.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1322-2014
Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
03-13-2014
05-21-2014
7,123 bottles
Recall Profile & Regulatory Data
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pain Free By Nature
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide including Puerto Rico
06-01-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
Batch or Lot Expiration Information
Lot# All lots
