XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health
Recall Number: D-1150-2016
Firm: Bee Extremely Amazed LLC
Classification: Class I
Status: Terminated
Report Date: 20160713
Initiation Date: 20151215
Termination Date: 20200423
Reason for Recall
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Product Description
XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health