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Neptune Resources LLC announced a voluntary recall of all lots of "Neptune's Fix Elixir," "Neptune's Fix Extra Strength Elixir," and Neptune's Fix Tablets due to the possible presence of tianeptine, the US Food and Drug Administration (FDA) announced.
Tianeptine, which has been called "gas station heroin" by some, is not FDA-approved for any medical use, and its presence in the products prompted the nationwide recall.
"The presence of tianeptine renders the products unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall," officials said.
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."
According to the FDA, 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 four-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. To date, there have been no adverse effects reported from the use of the recalled products, officials noted.
Distributors are being alerted by Neptune Resources, and customers can expect a form to be mailed out by the company laying out the details of the recall.
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