FDA recall D-267-2013

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.

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

Nationwide and Puerto Rico (through the internet).

Key facts

Status

Terminated

Initiation date

2012-12-10

Report date

2013-05-01

Termination date

2013-11-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canton, SD, United States

Primary source

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