Class II · Moderate risk
C-Urea 40% Bladder Instill
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Natureal Burn Fat Nature
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.
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
NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
Drug: Urea
- Recalling firm
- Inaffit, LLC
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0675-2016 · 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 Urea recalls
See all
Class II · Moderate risk
UREA 40% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class III · Low risk
Urea (50% Urea in a Cream Base)
Crystallization; complaints received by the manufacturer of crystals forming in product
Class III · Low risk
Remeven Cream
Crystallization; Complaints that cream appears to have crystallized
Class II · Moderate risk
All Germall
Lack of Processing Controls
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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