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FDA Issues Recall and Warning On Neptune's Fix Supplements Following Severe Adverse Events

The Food and Drug Administration (FDA) has been receiving severe adverse event reports linked to the use of Neptune's Fix products, including incidents of seizures, loss of consciousness, and even death. These products have the potential to interact in life-threatening ways with other medications that consumers may be taking. The FDA is actively investigating these reports in collaboration with local and state health departments.

In response to the concerning situation, Neptune Resources, LLC has voluntarily decided to recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets at the consumer level. Consumers, distributors, and retailers are advised to either dispose of these products or return them to the place of purchase immediately.

The FDA, in a letter dated January 11, 2024, has urged convenience stores, gas stations, and other organizations to cease the sale of Neptune’s Fix and any other products containing tianeptine. Tianeptine is a potentially dangerous substance not approved by the FDA for any medical use, yet it is being illegally sold with claims to improve brain function and treat various conditions, including anxiety, depression, pain, and opioid use disorder.

The FDA initially issued a warning on November 21, 2023, advising consumers against purchasing or using any Neptune’s Fix products or any other product containing tianeptine. The agency has received reports of severe adverse events, such as seizures and loss of consciousness leading to hospitalization, after the use of Neptune's Fix products. Consumers experiencing adverse reactions to any tianeptine product are urged to seek immediate medical help.

It is important to note that Neptune's Fix labels indicate the presence of tianeptine, but the products may also contain other harmful ingredients not listed on the label. These products are available for purchase online and at various locations, including gas stations, vape or smoke shops. The FDA is actively testing these products and will provide additional information as it becomes available. The agency continues to emphasize the risks associated with the use of tianeptine.

Some individuals use tianeptine as an alternative to opioids or for self-treatment of anxiety or depression, despite the FDA's warnings and lack of approval for such use. To address concerns and seek assistance, consumers are encouraged to call Poison Help at 1-800-222-1222 to connect to their local poison center.

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