Why it was recalled
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
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
Lot numbers, UPCs & expiration codes
All lots, all colors and all strengths
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0882-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 9, 2015
- FDA report date
- Jun 1, 2016
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lucy's Weight Loss (dba. Waisted With Lucy)
Original FDA data
Every field from FDA enforcement report D-0882-2016, exactly as published.
Show all FDA fields
- City
- Arlington
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 72820
- Address
- 813 Oram St
- Code information
- All lots, all colors and all strengths
- Postal code
- 76010-2837
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0882-2016
- Classification
- Class I
- Recalling firm
- Lucy's Weight Loss (dba. Waisted With Lucy)
- Product quantity
- Unknown
- Termination date
- Sep 27, 2021
- Reason for recall
- Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 9, 2015
- Initial firm notification
- Press Release
- Center classification date
- May 26, 2016