The Federal Commission for the Protection against Health Risks (Cofepris) has launched a health alert in relation to the falsification of the recombinant hepatitis B vaccine known as Provibac-B.
It has been detected that the counterfeit product is in a 200 mcg (20 ml) injectable suspension presentation and lacks the corresponding health authorization.
This alert aims to inform both health professionals and the general population about the falsification of this biological product that is manufactured by Probiomed and has its respective health registration.
The counterfeit product is identified by having the lot number 2526211014-1 on the secondary or external packaging, and 2566220/410-2 on the label of the vial.
In addition, it has an expiration date on the secondary packaging of October 6, 2023, while November 2023 appears on the product label.
The risk to the health of the population lies in the lack of information about the manufacturing, handling and storage conditions of the counterfeit product. Therefore, its safety, quality and effectiveness cannot be guaranteed.
Cofepris emphasizes the importance of always verifying that the lot numbers and expiration dates on the packaging of any product match. In case of doubts about the authenticity of a product, it is recommended to contact the holder of the corresponding health registration.
If you identify a product with the aforementioned characteristics, it is advisable not to purchase it and, if you have information about its possible commercialization, you can make the corresponding report online on the website gob.mx/cofepris or by calling the number 800 033 5050 .
If the counterfeit biological has been administered and if the patient experiences any adverse reaction or discomfort, they are urged to report it by following the link provided or by sending an email.
2023-09-10 22:25:00
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