D-1322-2014 Class I Terminated
FDA drug recall D-1322-2014 was initiated by Pain Free By Nature on March 13, 2014 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol. The recall status is terminated (terminated June 1, 2015). Affected quantity: 7,123 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 21, 2014
- Initiation Date
- March 13, 2014
- Termination Date
- June 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,123 bottles
Product Description
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 Pattern
Nationwide including Puerto Rico
Code Information
All lots