Product: 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disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Recall initiated: 20151215
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated