Recombinant hepatitis B vaccine found to be counterfeit.
The Council for the Prevention of Health Risks (Cofepris) has issued a health alert regarding counterfeit products of Provibac-B® (recombinant hepatitis B vaccine) injection suspension 200 µg.
The federal agency reported that health registration holder Probiomed SA de CV announced that they detected distribution of the product with the secondary packaging batch number 2526211014-1 and the vial label and date with the batch number 2566220/410-2. 2 The sub-package has an expiration date of October 23 and the expiry date on the label is November 23, emphasizing that the display of 20 ml is unauthorized and the batch number 2566220/410-2 is not believed to be manufactured by this enterprise and therefore poses a risk to the people. healthy.
As a result of this irregularity, Cofepris has issued a series of recommendations to the general public, health professionals, distributors and pharmacies: It is important to always verify that batch numbers and expiry dates match between any product packaging.
If there is any doubt about the originality of a product, please contact the health record holder so his or her identity can be confirmed. If you find that this product has the above characteristics, do not purchase it and if you have information about possible marketing, please file an appropriate health complaint.
when using it
If anyone uses the above products and experiences adverse reactions or discomfort, they can report it by email: pharmavigilancia@cofepris.gob.mx The Federal Board for the Protection of Health Risks assures that they will maintain health surveillance actions and will inform the public if new evidence is discovered, To prevent products, companies or institutions from not complying with current health legislation and posing a risk to public health.
This health alert can be consulted on the official Cofepris webpage in the category “Drug Health Alerts” and has been replicated in federal entities.