D-1149-2016 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 13, 2016
- Initiation Date
- December 15, 2015
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Distribution Pattern
Nationwide
Code Information
All lots