FDA Recall D-0881-2016
Lucy's Weight Loss (dba. Waisted With Lucy) · Arlington, TX
Class I — life-threatening Terminated 2611 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Reason for recall
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Recall record
- Recall number
D-0881-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2015-09-23
- Classified by FDA Center
- 2016-05-26
- FDA published
- 2016-06-01
- Terminated
- 2022-11-16
- Recalling firm
- Lucy's Weight Loss (dba. Waisted With Lucy)
- Firm location
- Arlington, TX