XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health
Reported: July 13, 2016 Initiated: December 15, 2015 #D-1150-2016
Product Description
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found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Details
- Recalling Firm
- Bee Extremely Amazed LLC
- Units Affected
- N/A
- Distribution
- Nationwide
- Location
- Jewett, OH
Frequently Asked Questions
What product was recalled? ▼
XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health. Recalled by Bee Extremely Amazed LLC. Units affected: N/A.
Why was this product recalled? ▼
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found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 13, 2016. Severity: Critical. Recall number: D-1150-2016.
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