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                Drug Safety and Availability

Drug Safety and Availability

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          FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risksDrug Safety and Availability FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks
  
  	
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**[1/23/2024]** FDA continues to receive severe adverse event reports after use of Neptune‘s Fix products, including seizures, loss of consciousness and death.

These products may interact, in life-threatening ways, with other medications a consumer may be taking. The agency is actively investigating adverse event reports in conjunction with local and state health departments.

Neptune's Elixir


Neptune's Elixir


Neptune's Elixir Tablets


Neptune Resources, LLC has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets to the consumer level. Consumers, distributors and retailers that have these products should either dispose of them or return them to place of purchase immediately.

FDA sent a letter on Jan. 11, 2024, to convenience store, gas station and other organizations urging retailers to stop selling Neptune’s Fix and any other tianeptine-containing products.

Call Poison Help at 1-800-222-1222 to connect to your local poison center.

**[11/21/2023]** FDA is warning consumers not to purchase or use any Neptune’s Fix products, or any other product with tianeptine -- a potentially dangerous substance that is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions.

4 bottles of Neptune's Fix, (lemon, cherry, chocolate and tropical) flavors
FDA has received severe adverse event reports after use of Neptune‘s Fix products, including seizures and loss of consciousness leading to hospitalization. Consumers who experience a bad reaction to any tianeptine product should seek immediate medical help.

Neptune's Fix labels state the product contains tianeptine, but the product may contain other harmful ingredients not listed on the label. These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or other locations. FDA is testing these products and will provide more information as it becomes available. FDA also continues to warn consumers about risks of using tianeptine.

Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
	Download and complete the form, then submit it via fax at 1-800-FDA-0178.

                                                                                  Content current as of:
      01/23/2024Drug Safety and Availability

          
                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections
 
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