FDA-Drug2016-07-13Class I
XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
Bee Extremely Amazed LLC
Hazard
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Sold states
Nationwide
Affected count
N/A
Manufactured in
85205 Sportsmans Club Rd, N/A, Jewett, OH, United States
Products
XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1149-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief