Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.
Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251.
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 CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Reason Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer…
Reason Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.
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