Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Baryta Carbonica 10X, Chromium Sulphuricum 10X, Crataegus Oxyacantha 10X, Digitalis Purpurea 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.
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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