Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide and Puerto Rico (through the internet).
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-267-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 10, 2012
- FDA report date
- May 1, 2013
- Quantity
- 17,555 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Brower Enterprises Inc
Original FDA data
Every field from FDA enforcement report D-267-2013, exactly as published.
Show all FDA fields
- City
- Canton
- State
- SD
- Status
- Terminated
- Country
- United States
- Event ID
- 63867
- Address
- 1002 E 5th St
- Code information
- All Lots
- Postal code
- 57013-1925
- Report date
- May 1, 2013
- Product type
- Drugs
- Recall number
- D-267-2013
- Classification
- Class I
- Recalling firm
- Brower Enterprises Inc
- Product quantity
- 17,555 Bottles
- Termination date
- Nov 14, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico (through the internet).
- Recall initiation date
- Dec 10, 2012
- Initial firm notification
- Letter
- Center classification date
- Apr 23, 2013