KANSAS CITY, Mo., Jan. 28, 2024 /PRNewswire-PRWeb/ — Neptune Resources, LLC is voluntarily recalling All lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets to the consumer level. Neptune Resources LLC’s distribution channels have not reported any adverse events from the use of its products. The products are being recalled because they contain tianeptine, an ingredient that is not FDA-approved for any medical use. The presence of tianeptine renders the products unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall.
Risk Statement: The FDA has advised that: There is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger. In addition, individuals could unintentionally overdose and experience serious and potentially life-threatening risks including confusion, seizures, drowsiness, dry mouth, and shortness of breath, which may be exacerbated by alcohol use. Further, the risks of adverse effects associated with use of tianeptine along with antidepressants, known as monoamine oxidase inhibitors (MAOls), are potentially serious and life-threatening.
Neptune’s Fix Elixir and Extra Strength Elixir are used as a supplement and are packaged in amber glass bottles with a “shrink sleeve” label that covers the entire cap/bottle and is perforated at the cap to facilitate opening. Neptune’s Fix tablets are packaged in 20-count blister packs held in small boxes or 4-count foil packets. All Neptune’s Fix products are being recalled. The product can be identified by the name Neptune’s Fix and its logo which is an illustration of the Roman God Neptune with a green beard and a trident. The products were distributed Nationwide to wholesale and retail customers.
Neptune Resources is proactively notifying its distributors and customers by form of a mailed out recall letter and is arranging for the return of all recalled products.
Consumers/distributors/retailers that have product which is being recalled should stop using it and either destroy it or return it to place of purchase immediately.
Consumers with questions regarding this recall can contact Neptune Resources at 816-256- 2071, Monday-Friday 9am-6pm CT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.