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-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Cholesterinum 10X, Avena Sativa 12X, Cynara Scolymos 12X, Phosphorus 12X, Oroticum Acidum 13X, Aesculus Hipposcastanum 24X, Carduus Marianus 24X, Chelidonium Majus 24X, Cimicifuga Racemosa 24X, Cinchona Officinalis 24X, Colocynthis 24X, Histaminum Hydrochloricum 24X, Lycopodium Clavatum 24X, Sulphur 24X, Tataxacum Officinale 24X, Veratrum Album 24X, Sepia 30X, Strontium Carbonicum 30X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured 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…
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.