A nationwide recall of supplements is affecting products sold in North Carolina 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).