Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-1149-2016

December 15, 2015

Class I

Product summary

Firm
Bee Extremely Amazed LLC
Event
Event 71187
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-1149-2016

Official wording

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disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

Code information: All lots

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.