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Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of RISPERDAL® Tablets and One Lot of Risperidone Tablets
Date:6/17/2011

ww.fda.gov/medwatch/getforms.htm.  Mail to address on the pre-addressed form.
  • Fax:  1.800.FDA.0178

  • We conducted an investigation involving our suppliers to evaluate the potential source of this TBA issue.  This investigation revealed that some of the wooden pallets used by one of our suppliers in its warehouse were contaminated with TBA.  In addition, some of the packaging components manufactured by our supplier were exposed to these pallets.  We have initiated a deeper investigation to determine the potential impact of these findings to other products.  We also are working with peer companies to better understand how and where TBA is entering and impacting our supply chains and what we can do to further mitigate this exposure.  

    The voluntary recall, being implemented with the knowledge of the U.S. Food and Drug Administration (FDA), was initiated after enhanced surveillance and complaint monitoring programs escalated two odor-related reports.  

    RISPERDAL® 3mg Tablets are yellow and imprinted with "JANSSEN" on one side and R3 on the other.  Risperidone 2mg Tablets are orange and imprinted "PATR" on one side and R2 on the other.

    About Ortho-McNeil-Janssen Pharmaceuticals, Inc.Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) provides medicines for an array of health concerns, including central nervous system disorders, such as schizophrenia and epilepsy; women's health; urology; gastrointestinal conditions; and infectious diseases. The company strives to provide innovative, high quality, safe and effective treatments and continually seeks new opportunities to offer solutions for unmet health care needs. Ortho-McNeil-Janssen Pharmaceuticals, Inc. is headquartered in Titusville, New Jersey.

    About JanssenJanssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, New Jersey, and is the only large pharmaceutical company
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