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Recall Observatory FDA recall evidence

Drug product

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.

D-267-2013

December 10, 2012

Class I

Product summary

Firm
Brower Enterprises Inc
Event
Event 63867
Status
Terminated
Classification
Class I
Quantity
17,555 Bottles
Official record key
drug-enforcement:D-267-2013

Official wording

Reason: 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.

Code information: All Lots

Distribution pattern: Nationwide and Puerto Rico (through the internet).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.