COFEPRIS Warns of Fake Diabetes Drug in Mexico

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has issued an updated health alert related to the falsification of the medication Jardianz 25 mg and 10 mg (Empagliflozina), used in the treatment of type 2 diabetes. The authority confirmed the circulation of a counterfeit batch identified as 903801, which does not correspond to valid expiration dates and is not authorized for the Mexican market, representing a health risk for consumers.

According to the update disseminated by COFEPRIS and made known by the Coahuila Ministry of Health, the company holding the sanitary registration, Boehringer Ingelheim Promeco, S.A. de C.V., reported the detection of a falsified Jardianz 10 mg, packaged in a box with a bottle of 60 tablets. The counterfeit product presents:

• Batch Number: 903801
• Expiration Date: NOV25
• Presentation: Bottle with 60 tablets

The pharmaceutical company clarified that a batch with that number does exist, but its real expiration date corresponds to May 2021, confirming that the article currently circulating in the market is a falsified product.

Health Risks from Consuming Counterfeit Medications

COFEPRIS indicated that the real composition of the falsified drug is unknown, as well as the conditions of manufacturing, storage, or transport. Therefore, its safety, efficacy, or quality is not guaranteed, and it is considered a sanitary risk for those who use it to control their diabetes. In that sense, the sanitary authority asked users and pharmaceutical establishments:

• Do not acquire Jardianz (Empagliflozina) in bottle presentation.
• Do not use products with batch number 903801, regardless of the indicated expiration date.
• Report information about its sale through the corresponding sanitary complaint.
• Suspend its use immediately if the described product is being consumed and consult a health professional.
• Notify adverse reactions on the VigiRAM platform or via email: farmacovigilancia@cofepris.gob.mx

How to Identify Authorized Medications in Mexico

COFEPRIS recommends acquiring medications only in authorized establishments, checking that the packaging presents:

• Valid batch number
• Coherent expiration date
• Sanitary registration
• Official seals and characteristics

In case of doubt, users can verify the information on the official COFEPRIS portal or request guidance at health institutions.