FDA Recall D-267-2013
Brower Enterprises Inc · Canton, SD
Class I — life-threatening Terminated 339 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-267-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and Puerto Rico (through the internet).
- Recall initiated
- 2012-12-10
- Classified by FDA Center
- 2013-04-23
- FDA published
- 2013-05-01
- Terminated
- 2013-11-14
- Recalling firm
- Brower Enterprises Inc
- Firm location
- Canton, SD