Pink Bikini capsules recalled for undeclared dangerous ingredients
Lucy's Weight Loss System is recalling Pink Bikini capsules because they contain undeclared Sibutramine, Phenolphthalein, and/or Diclofenac.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Lucy's Weight Loss System (dba Waisted With Lucy) is recalling Pink Bikini capsules in all colors and strengths, packaged in 30-count bottles. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall is being conducted because the capsules contain undeclared Sibutramine, Phenolphthalein, and/or Diclofenac. These ingredients were not listed on the product label.
The recall covers all lots of the product distributed nationwide. Consumers who have purchased these capsules should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Lucy's Weight Loss (dba. Waisted With Lucy)
- Category
- Drug — Weight Loss Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All lots
- all colors and all strengths
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Lucy's Weight Loss (dba. Waisted With Lucy) under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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