D-0882-2016 Class I Terminated
FDA drug recall D-0882-2016 was initiated by Lucy's Weight Loss (dba. Waisted With Lucy) on December 9, 2015 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac. The recall status is terminated (terminated September 27, 2021). Affected quantity: Unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2016
- Initiation Date
- December 9, 2015
- Termination Date
- September 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
Reason for Recall
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Distribution Pattern
Nationwide
Code Information
All lots, all colors and all strengths