Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza Brooks City-Base, Texas 78235. NDC: 0064-1080-11
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 Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Reason Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Reason Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Reason Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Reason Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
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