Dietary Supplement Recalled for Undeclared Drug Ingredients
Brower Enterprises Inc. is recalling WOW Health Enterprises Dietary Supplement because it contains undeclared drug ingredients, making it an unapproved drug.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Brower Enterprises Inc. is recalling its WOW Health Enterprises Dietary Supplement, 30 Caplets. The product is distributed by Health Enterprises in Canton, SD, and manufactured by Riger Natural, S. A. in Mexico. A total of 17,555 bottles were distributed nationwide and in Puerto Rico through the internet.
The recall is being conducted because the product contains undeclared drug ingredients, which makes it an unapproved drug. FDA sample analysis identified the presence of methocarbamol, dexamethasone, and diclofenac in the supplement. The recall covers all lots of the product.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- 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.
- Manufacturer
- Brower Enterprises Inc
- Category
- Drug — Dietary Supplement
- Affected units
- 17,555
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
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