Status
Terminated
Drug Enforcement D-267-2013
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.
Classification
Class I
Report Date
May 1, 2013
Termination Date
November 14, 2013
Product Information
- 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.
- Product quantity
- 17,555 Bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico (through the internet).
Location & Firm
- Recalling firm
- Brower Enterprises Inc
- Address
-
1002 E 5th St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-267-2013
- Event ID
- 63867
- Recall initiation date
- December 10, 2012
- Center classification date
- April 23, 2013
- Code info
- All Lots
- More code info
- —