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

Recall Number: D-1149-2016

Firm: Bee Extremely Amazed LLC

Classification: Class I

Status: Terminated

Report Date: 20160713

Initiation Date: 20151215

Termination Date: 20200423

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disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

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