Drug product
Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
D-0879-2016
Product summary
- Event
- Event 72269
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0879-2016
Official wording
Reason: Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Code information: All lots
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.