XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
FDA Recall #D-1149-2016 — Class I — December 15, 2015
Product Description
XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
Reason for Recall
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disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Recalling Firm
Bee Extremely Amazed LLC — Jewett, OH
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide
Code Information
All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated