TOPIC: Neptune's Fix by Neptune Resources: Recall - Due to Presence of Tianeptine
AUDIENCE: Consumer, Health Professional, Pharmacy
ISSUE: Neptune Resources is recalling All lots of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets 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.
To date, Neptune Resources distribution channels have not reported any adverse events from the use of its products.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Neptune's Fix Elixir and Extra Strength Elixir are used as a supplement.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.
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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.
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Consumers with questions regarding this recall can contact Neptune Resources at 816-256- 2071, Monday-Friday 9am-6pm CT.
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