D-1150-2016 Class I Terminated
FDA drug recall D-1150-2016 was initiated by Bee Extremely Amazed LLC on December 15, 2015 and is designated Class I. 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 p… The recall status is terminated (terminated April 23, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- July 13, 2016
- Initiation Date
- December 15, 2015
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Distribution Pattern
Nationwide
Code Information
All lots