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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Some Lots of Oribe Serene Scalp Densifying Shampoo by Kao USA: Recall - May Be Contaminated with Pluralibacter gergoviae Bacteria
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology
ISSUE: Kao USA is recalling select lots of its Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz) in the U.S. and Canada due to the detection of Pluralibacter gergoviae bacteria.
Though Pluralibacter gergoviae bacteria pose little medical risk to healthy people, those with certain health issues such as weakened immune systems may be more susceptible to infection by the bacteria. Regardless of health status, Kao USA is urging anyone who has affected products as specified below to discontinue use.
Further investigation to confirm the scope of the issue is still ongoing.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The products being recalled are sold as scalp densifying shampoo.
RECOMMENDATIONS:
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To report any adverse events experienced with the use of this product, arrange for a replacement or for any questions, contact the Kao Professional Hair Technical Hotline at 800-333-2442 or email oribecomplaints@kao.com.
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The company is asking retail and salon partners to remove affected lots from use and/or sale and return them to us for safe disposal.
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Health care professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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