Class I — High risk. Reasonable probability of serious harm or death.
Microbial contamination
Dr. King's Natural Medicine Homeopathic Breakthrough for the Common Cold, 1 fl. oz. (29.6 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955122111, NDC 57955-1221-1
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 Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
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