Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations
Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15
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: 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
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
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