Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured a...
FDA Recall #D-0882-2016 — Class I — December 9, 2015
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.
Recalling Firm
Lucy's Weight Loss (dba. Waisted With Lucy) — Arlington, TX
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
Unknown
Distribution
Nationwide
Code Information
All lots, all colors and all strengths
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated