FDA Recall D-0961-2016
Novacare, LLC · Murray, UT
Class I — life-threatening Terminated 737 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org.
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Recall record
- Recall number
D-0961-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2015-08-24
- Classified by FDA Center
- 2016-06-06
- FDA published
- 2016-06-15
- Terminated
- 2017-08-30
- Recalling firm
- Novacare, LLC
- Firm location
- Murray, UT