Product: XCEL ADVANCED Capsules, 350mg, 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found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.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