Class I · High risk
Shorts on the Beach capsules
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Pink Bikini Strong Formula capsules
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
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
- Recalling firm
- Lucy's Weight Loss (dba. Waisted With Lucy)
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0879-2016 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Lucy's Weight Loss (dba. Waisted With Lucy)
All 2015 recalls
Class I · High risk
Pink Bikini capsules
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Class I · High risk
Shorts on The Beach Golden Edition by Pink Bikini
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Class I · High risk
Shorts on The Beach Strong Formula by Pink Bikini capsules
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Other chemical / undeclared recalls from 2015
All chemical / undeclared recalls
Class I · High risk
APEXXX tablets
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Class I · High risk
Jenesis Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Class I · High risk
Oasis Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Class I · High risk
La' Trim Plus Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
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