FDA warns of unapproved H1N1 products
This article was originally published in The Tan Sheet
Executive SummaryFDA warns Tib Molbiol in an Aug. 24 letter that its LightMax InfA swine H1 kit to test for swine flu is unapproved and unauthorized for sale. In a warning sent by e-mail to the online firm, the agency requests Tib Molbiol "immediately cease marketing" the kit and within 48 hours of receiving the warning letter inform FDA how it will address the violations. The agency added the test product to a list of 131 other "fraudulent products" that "illegally" market unapproved or unauthorized products related to the 2009 H1N1 flu at 1www.accessdata.fda.gov/scripts/h1n1flu
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