XCEL Capsules recalled over undeclared fluoxetine

Recall date

December 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Bee Extremely Amazed LLC recalls XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health

Recall number

D-1149-2016

FDA classification

Class I

Brand / firm

Bee Extremely Amazed LLC

Sold / distributed

Nationwide

Why it was recalled

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disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health