Nationwide FDA Recall…Children at Risk of Self-Harm - MedWaste Management Nationwide FDA Recall…Children at Risk of Self-Harm - MedWaste Management

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FDA Recall Neptune's Fix Children may self harm Children Suicide Risk

Nationwide FDA Recall…Children at Risk of Self-Harm

The FDA has announced a total recall of all lots of Neptune’s Fix, a series of over-the-counter substances marketed to improve brain function and treat pain, anxiety, and depression.

  • On January 11, 2024, the FDA notified gas stations and convenience stores via mail that Neptune’s Fix was considered dangerous. They urged all retailers to stop selling the product immediately and to share the message with others who might carry the substance.
  • On January 23, 2024, The FDA announced a warning to the public concerning Neptune’s Fix products. They reported having received adverse event reports claiming that users had experienced seizures, loss of consciousness, and death.
  • Finally, as of January 29, 2024, the FDA is officially announcing a complete and total recall of all lots. The substance contains an unapproved drug that causes life-threatening events, particularly in those taking MAOIs (monoamine oxidase inhibitors). In children and young adults, there is a high probability of suicidal ideation after consuming the drug.

 

If you or someone you know is experiencing thoughts of self-harm, contact the Suicide and Crisis Lifeline immediately by calling or texting 988.

 

 

RECALL SUMMARY

Date of Recall:

Announced: January 28, 2024

Public Notification: January 29, 2024

Name(s) of Drug:

  • Neptune’s Fix Elixir
  • Neptune’s Fix Extra Strength Elixir
  • Neptune’s Fix Tablets

Company Name:

Neptune Resources, LLC

Drug Indication:

Pain

Brain Function

Anxiety

Depression

Neptune's Fix bottles FDA
Neptune's Fix box of tablets FDA
FDA Recall Neptune's Fix Elixir bottle
Neptune's Fix elixir bottle drug recall look like

www.fda.gov

Product Description

Retailers nationwide carry Neptune’s Fix products, including gas stations and convenience stores. The drug was available over the counter and did not require a prescription from a physician.

The elixir comes packaged in an amber glass bottle with a label that comes in several colors, including yellow, pink, green, and orange.

Tablets are packaged in 20-count blister packs and sold in small boxes. Some smaller 4-count foil packs were available as well.

All Neptune’s Fix products bore the image of the Roman God Neptune with a green beard and trident.

Reason for Recall

The FDA received reports of consumers experiencing seizures, loss of consciousness, and death after consuming the product. FDA inspectors found that the substance contains tianeptine, a drug that is not approved for use in the United States.

Impacts

Tianeptine is a hazardous drug and is not approved for use. Furthermore, when taken by children or young adults, there is a reasonable probability that the consumer will experience suicidal ideation and behaviors.

There is no approved dosage of the drug, and therefore, the use of Neptune’s Fix poses a serious overdose hazard that may lead to confusion, seizures, drowsiness, dry mouth, or shortness of breath. These symptoms are exacerbated further when combined with alcohol use.

Patients taking MAOIs (monoamine oxidase inhibitors) to treat their depression face serious and life-threatening risks as the drugs interact.

Recall Lot Information

ALL LOTS of Neptune’s Fix products are involved in the recall.

Do you possess Neptune’s Fix products? Here’s what you should do to comply with the recall:

Consumers

  1. DO NOT USE Neptune’s Fix products
  2. Immediately notify your doctor if you have used the recalled drug.
  3. Closely monitor your health for adverse symptoms and notify your doctor of any changes.
  4. Consumers may contact Neptune’s Resources at (816) 256-2071. They are available Monday through Friday from 9:00 a.m. to 6:00 p.m. (CT).
  5. If you are currently experiencing or have experienced an adverse reaction to the medication, notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  6. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Neptune’s Resources at (816) 256-2071. Notify them of any recalled batches that have already been sold to consumers.
  3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Neptune’s Resources at (816) 256-2071. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal for the healthcare industry and the general public alike. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

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Tammy McKinney, Nurse Writer

Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!


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