FDA demands records from bottled water company linked to hepatitis outbreak
A bottled water company continues to refuse to cooperate with an FDA investigation of non-viral hepatitis. The agency reports that the water is the only common denominator among the outbreak patients.
“Given a lack of cooperation by the firm, FDA investigators have been unable to complete investigations at the ‘Real Water’ Inc. facilities in Henderson, NV, and Mesa, AZ, and have not been provided with requested records. As a result, on March 23, FDA issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act,” according to the public alert from the Food and Drug Administration.
“Consumption of ‘Real Water’ brand alkaline water is the only common link identified among all of these cases to date.”
Five people in Nevada are confirmed sick from non-viral hepatitis and all five have been admitted to hospitals. The U.S. Centers for Disease Control and Prevention is assisting the FDA and the Southern Nevada Health District with the investigation.
The company issued a recall of all of its water March 24. The products include but are not limited to: 5-gallon containers sold through home delivery/subscription; bottles sold on-line and in stores; and the “Real Water” concentrate sold on-line, according to the FDA.
According to the firm’s press release, the recall includes 1.5 liter, 1 liter, 500-ml and 1 gallon ready-to-drink alkaline water bottles and 4-ounce bottles of “Real Water” concentrate.
Anyone who has consumed any of the recalled water and developed symptoms of hepatitis should seek medical attention. Also, it can take up to 50 days for symptoms to develop, so anyone who has consumed the water recently should monitor themselves for symptoms in the coming weeks.
Symptoms of all types of hepatitis, including non-viral hepatitis, are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes and/or skin.
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Source: https://www.foodsafetynews.com/2021/03/fda-demands-records-from-bottled-water-company-linked-to-hepatitis-outbreak/
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