FDADecember 15, 2015drug

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

Official recall recorded by the U.S. Food & Drug Administration.

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disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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