FDA Warning: Counterfeit Ozempic on the Market - MedWaste Management FDA Warning: Counterfeit Ozempic on the Market - MedWaste Management

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Counterfeit Ozempic FDA Warning

FDA Warning: Counterfeit Ozempic on the Market

In cooperation with Ozempic’s manufacturer, Novo Nordisk, the FDA has issued a stark warning about the presence of counterfeit Ozempic (semaglutide) injections on the market. This isn’t the first time we’ve reported on an issue with the drug. In July, we posted a notice concerning research looking into the drug’s safety after several patients committed suicide while taking it.

It remains unclear how counterfeit products entered the US drug supply, but the FDA is working to identify breaches in the supply chain and remove any unauthorized products.

As of the writing of this notice, the FDA has received reports of at least five adverse events related to the counterfeit pens.

SUMMARY

Date of Notice:

Announced: December 22, 2023

Public Notification: December 22, 2023

Name(s) of Drug:

Ozempic (semaglutide)

Company Name:

Novo Nordisk

Drug Indication:

Weight Loss

Type 2 Diabetes

Difference between real and counterfeit Ozempic Difference between real and counterfeit Ozempic

Product Description

Ozempic is distributed by authorized pharmacies nationwide and is available by prescription only. The product is delivered in pen form and delivers a 1mL injection.

How to distinguish between an authentic and counterfeit Ozempic pen:

Authentic
Counterfeit
The paper tab over the needle is printed with “NovoFine Plus.” The paper tab over the needle is printed with “NovoFine.”
The inner needle cover is transparent. The inner needle cover has a blue transparent cover.
The paper tab on the needle is imprinted with the needle lot number. The paper tab on the needle is imprinted with the carton lot number (as noted in the chart below).

Reason for Notice

Through adverse event reporting, the FDA has been made aware of an unknown number of counterfeit Ozempic (semaglutide) pens on the market.

Impacts

It is unknown what is contained within the counterfeit pens. There is extreme danger in a user injecting an unknown substance. The substance may be toxic, may interact with other medications, or may be incorrectly dosed.

Additionally, there is concern about how or where the counterfeit pens were created. They may or may not be sterile and pose a high risk of infection for users.

Lot Information

Consumers who use Ozempic (semaglutide) should carefully check their pens for indications that it may be counterfeit. Also, check for the lot number and serial number listed below. If the information matches, read further to determine what actions must be taken to participate in proper reporting procedures.

Counterfeit Ozempic

Product
Lot #
Serial #
Ozempic (semaglutide)

NAR0074

430834149057

FDA.gov

Have you found that your medication is counterfeit? Here’s what you should do:

Consumers

  1. Call your doctor right away. Report the use of the counterfeit medication. Do not use any other counterfeit pens.
  2. Monitor your health for any adverse symptoms and notify your physician if you note any concerns.
  3. Consumers with questions may contact Novo Nordisk at 1 (800) 727-6500. They are available Monday-Friday from 8:30 a.m. to 6 p.m. EST.
  4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  5. If you know of an organization selling counterfeit medications, such as Ozempic, report the sales immediately to the FDA consumer complaint coordinator for your state. You can also report the sellers via this online 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 notice immediately.
  2. Contact Novo Nordisk at 1 (800) 727-6500. They are available Monday-Friday from 8:30 a.m. to 6 p.m. EST. Notify them of any counterfeit pens you have already sold to consumers.
  3. Notify affected consumers of counterfeit batches they have or will receive.
  4. Report known tampering with the supply chain to your state’s FDA consumer complaint coordinator. You can also report criminal activity via this online form.
  5. 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 Novo Nordisk at 1 (800) 727-6500. They are available Monday-Friday from 8:30 a.m. to 6 p.m. EST. Notify them of any counterfeit pens that have already been shipped to retailers.
  3. Notify affected retailers of counterfeit batches they have or will receive.
  4. Report known tampering with the supply chain to your state’s FDA consumer complaint coordinator. You can also report criminal activity via this online form.
  5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, RN, creator 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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