Class I — High risk. Reasonable probability of serious harm or death.
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
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