A nationwide recall of supplements is affecting products sold in Ohio after it was determined the supplements contained a non-FDA approved ingredient that could lead to "life-threatening" side effects.
Neptune Resources, LLC issued a voluntary recall of all lots of its Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir and Neptune's Fix Tablets due to the presence of tianeptine, according to a recall notice published by the U.S. Food & Drug Administration on January 29. The antidepressant is not approved by the FDA for medical use.
While no averse events from use of the products have been reported, the FDA advises that "there is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger." Additionally, consumers could unintentionally overdose and experience serious symptoms like seizures, shortness of breath, confusion, drowsiness and dry mouth.
Tianeptine could also lead to adverse and potentially life-threatening effects if used in conjunction with antidepressants known as monamine oxidase inhibitors (MAOIs).
The Neptune Fix products can be identified by the logo, which features an illustration of the Roman God Neptune with a green beard holding a trident. The elixirs are packaged in amber glass bottles while the tablets are packaged in 20-count blister packs in small boxes or in 4-count foil packets.
Neptune Resources has notified both distributors and consumers of the recall. The company advises that consumers stop using the affected products immediately and either destroy them or return them to the place of purchase. Customers with questions regarding the recall can contact Neptune Resources at 816-256-2071.
For more information about the recall or to see photos of the impacted products, visit fda.gov.