TAGS: Toiletries
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Absara Cosmetics S.A.P.I DE C.V. for its Fragrance Free Vlanc + Plur Hand Sanitizer Rinse Free Formulated with 70% of alcohol with aloe vera & glycerin. This hand sanitizer was detained and refused admission at the United States border.
Ethanol Present at Lower Levels
The results of the FDA laboratory testing of a batch of this product demonstrates that it is adulterated. The
hand sanitizer is labeled to contain 70% volume/volume (v/v) of the active ingredient alcohol (ethanol). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained only 58% v/v ethanol.
This hand sanitizer drug product is adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the products lower than that which is declared on its labeling.
Follow-up Investigation into Hand Sanitizer
CDC recommends that, if soap and water are not readily available, consumers use an alcohol-based hand sanitizer that contains not less than 60% alcohol (ethanol). This is the minimum active ingredient concentration of ethanol specified in the 1994 Tentative Final Monograph for Health-Care Antiseptic Drug Products (59 FR 31402), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016).
FDA has requested a detailed follow-up investigation into the hand sanitizer drug. The organization will require the following:
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A list of all raw materials used to manufacture this hand sanitizer drug products, including the suppliers’ names, addresses, and contact information
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A list of all batches of any hand sanitizer drug products shipped to the United States by Absara Cosmetics, and a full reconciliation of all material distributed
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Copies of the complete batch records for all batches distributed to the United States
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A list of appropriate chemical and microbial test methods and specifications used to analyze each lot of your components and drug product before making a lot disposition decision, and the associated written procedures
Source: FDA