FDA-Drug2016-07-13Class I

XCEL ADVANCED Capsules, 350mg, 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found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.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 ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1150-2016

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