Class II · Moderate risk
B-Lipo
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
Slim-K
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
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
SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
- Recalling firm
- Bethel Nutritional Consulting, Inc
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1207-2015 · 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 Bethel Nutritional Consulting, Inc
All 2014 recalls
Class I · High risk
Bethel Advance
Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Class I · High risk
Quick Thin
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Class I · High risk
Bethel 30 capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.
Other chemical / undeclared recalls from 2014
All chemical / undeclared recalls
Class II · Moderate risk
Ginseng Kianpi Pil
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Class II · Moderate risk
MAYHEM capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Class I · High risk
Forever Beautiful BEE POLLEN
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Class I · High risk
Forever Beautiful INFINITY
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
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