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Modernize [5-1-2024] The FDA is providing this update to include images of genuine, FDA-approved Botox products.

Approved by the FDA Botox available in vials of 100 and 200 units. Approved by the FDA Botox Cosmetic available in vials of 50 and 100 units. FDA-approved Botox products list the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial.

The product description on the outer box is one of the following:

• “BOTOX® COSMETIC / onabotulinum toxin A / for injection”
• “OnabotulinumtoxinA / BOTOX® / for injection”

The manufacturer identified on the outer carton is one of the following:

• “Allergan Aesthetics / An AbbVie Company”
• “Allergan”
• “Abbvie”

Visit the Allergan website for more images of the original Botox cosmetic products.

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[4-16-2024] The FDA is warning healthcare professionals and consumers that unsafe counterfeit versions of Botox (botulinum toxin) have been found in many states and administered to consumers for cosmetic purposes.

The FDA is aware of adverse events, including hospitalizations, associated with counterfeit Botox. Symptoms included blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness, and difficulty lifting one’s head after injecting these products. These symptoms are similar to those seen when botulinum toxin spreads to other parts of the body.

The FDA takes reports of counterfeit products seriously and works closely with the Centers for Disease Control and Prevention (CDC), government health services and manufacturers to help protect the country’s drug supply. The FDA’s investigation is ongoing and the agency is currently working with AbbVie (the manufacturer of Botox) to identify, investigate and remove suspected counterfeit Botox products found in the US.

These incidents have occurred when counterfeit Botox is injected by licensed and unlicensed individuals and/or in non-medical or unlicensed facilities. The products appear to have been purchased from unauthorized sources. Medicines purchased from unlicensed sources may be incorrect, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe.

Information for Health Professionals

• Buying and dispensing counterfeit products puts your patients at risk.
• Check the product for any signs of tampering before using it.
• Federal law requires all health care providers who administer or dispense prescription drugs to purchase these products only from authorized sources.
• Visit the FDA website for information on how to safely buy prescription drugs for your patients: Know Your Source: Protecting Patients from Unsafe Drugs.

Information for consumers

• If you experience any of the symptoms listed above after injecting botulinum toxin products, contact a healthcare professional or go to the emergency room.
• Confirm with your healthcare professional that you are getting a product from an authorized source.
• Ask your healthcare professional if they are licensed and trained to administer the product.

Signs of botox fake versions

There are some similarities between fake Botox products and FDA-approved Botox.

AbbVie manufactures its original Botox products in dosage forms of 50, 100 and 200 units. The product descriptions on the outer boxes are either “BOTOX® COSMETIC / onabotulinumtoxinA / for injection” or “OnabotulinumtoxinA / BOTOX® / for injection”. The manufacturer listed on the outer box is either “Allergan Aesthetics / An AbbVie Company” or “abbvie”. FDA-approved Botox lists the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial.

Currently, there is no indication that the reported events were associated with AbbVie’s FDA-approved Botox, and the genuine product should be considered safe and effective for its intended and approved uses.

Counterfeit product includes counterfeit outer box and vial. The counterfeit product can be identified by one or more of the following:

• outer carton and vial contain lot number C3709C3
• the outer box lists the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”
• the outer carton and vial indicate doses of 150 units, which is not a unit manufactured by AbbVie or Allergan
• the outer box contains language other than English