FDA-Drug2013-05-01Class I

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.

Brower Enterprises Inc
Hazard

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.

Sold states
Nationwide and Puerto Rico (through the internet).
Affected count
17,555 Bottles
Manufactured in
1002 E 5th St, Canton, SD, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-267-2013

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