Pink Bikini Strong Formula capsules recalled for undeclared ingredients
Lucy's Weight Loss System is recalling Pink Bikini Strong Formula capsules because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA/ANDA.
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 mandates a severity score of 5 per the rubric.
Plain-English summary
Lucy's Weight Loss System (dba. Waisted With Lucy) is recalling Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottles. The product was manufactured and distributed by Lucy's Weight Loss System in Arlington, Texas, and distributed nationwide.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared sibutramine and phenolphthalein.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. All lots of the product are affected.
The recalled product
- 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
- 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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
See all 3 products in this recall →Related recalls
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