Class I · High risk
Burn 7 Capsules
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
vitaliKOR Ready When You Are
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
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
vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148.
- Recalling firm
- Vitality Research Labs LLC
- Origin
- NV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1364-2014 · 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 chemical / undeclared recalls from 2013
All chemical / undeclared recalls
Class I · High risk
Dream Body Slimming Capsule
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.
Class I · High risk
Magic Slim capsules
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
Class I · High risk
Dr. Ming's Chinese Capsule
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
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