D-267-2013 Class I Terminated
FDA drug recall D-267-2013 was initiated by Brower Enterprises Inc on December 10, 2012 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved dru… The recall status is terminated (terminated November 14, 2013). Affected quantity: 17,555 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2013
- Initiation Date
- December 10, 2012
- Termination Date
- November 14, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,555 Bottles
Product Description
WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico.
Reason for Recall
Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.
Distribution Pattern
Nationwide and Puerto Rico (through the internet).
Code Information
All Lots