FDA Recall D-0969-2016
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 Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers. TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
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-0969-2016- 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