Class I — High risk. Reasonable probability of serious harm or death.
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA
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 Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason cGMP deviations
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Reason Microbial contamination
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
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