Investigation of Acute Non-viral Hepatitis Illnesses – “Real Water” Brand Alkaline Water (March 2021)

Investigation of Acute Non-viral Hepatitis Illnesses – “Real Water” Brand Alkaline Water (March 2021)

The FDA, along with the CDC and the Southern Nevada Health District, is investigating a number of reports of acute non-viral hepatitis in the state of Nevada associated with “Real Water” brand alkaline water.

The FDA has become aware that “Real Water” brand alkaline water is still being offered for sale through online retailers. The agency is working to locate any remaining products to ensure they are no longer available to consumers. The FDA will continue to monitor this situation closely and follow up with retailers as we become aware of recalled products being offered for sale.

In addition, the FDA is conducting an audit to gauge the effectiveness of the voluntary recall initiated by Real Water, Inc. As of March 31, 2021, the audit has found that, prior to contact by FDA, a number of distributors had not received notification directly from the firm about the recall. Additionally, as of March 31 2021, Real Water Inc. is still promoting the product via social media despite issuing a recall announcement.

Therefore, the FDA is reiterating that it is crucial that consumers, restaurants, distributors, and retailers not drink, cook with, sell, or serve “Real Water” alkaline water.

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 and on March 25, FDA issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act.

Consumption of “Real Water” brand alkaline water is the only common link identified among all of these cases to date. This brand of alkaline water is owned by Real Water Inc., headquartered in Mesa, Arizona.

Although the investigation is ongoing, current epidemiologic information indicates that this alkaline water product may be the cause of the illnesses.

As this outbreak investigation continues, the FDA will provide additional updates to this advisory as more information becomes available.

Recommendation

Consumers, restaurants, distributors, and retailers should not drink, cook with, sell, or serve “Real Water” alkaline water, until more information is known about the cause of the illnesses. Further, FDA advises that this water not be served to pets. These products include but are not limited to: 5-gallon and 3-gallon containers (sold through home delivery/subscription), bottles of various sizes (sold on-line and in stores), and the “Real Water” concentrate (sold on-line).

The public is urged to report any product being offered for sale to the FDA Consumer Complaint Coordinator in their region.

According to the firm’s press release, the recalled alkaline water products are available nationwide, however the 5-gallon containers were distributed to the following areas: greater Las Vegas, NV area, central California coastal region (North of Los Angeles, CA, and South from Santa Barbara, CA), and Phoenix, AZ.

The firm’s press release also includes 1.5 liter, 1 liter, 500 ml and 1 gallon ready-to-drink alkaline water bottles and the 4 oz. concentrate.

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 jaundice. Those experiencing these symptoms should contact their doctor.

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