Mexico City. The Federal Commission for the Protection against Health Risks (Cofepris) issued an alert because it identified the circulation of a counterfeit vaccine, Provibac-B recombinant against Hepatitis B. It presents two different lot numbers: 2526211014-1 on the box and 566220/410- 2 on the bottle label. Also the expiration dates vary on both sites.
It indicated that the product was detected in the presentation of an injectable suspension of 200 micrograms (mcg) or 20 milliliters and does not have health authorization.
The original vaccine is manufactured by the Probiomed pharmaceutical laboratory, it is the holder of the health registry and offers presentations of 10, 20 and 200 mcg.
The regulatory agency pointed out that the ampoule with the aforementioned characteristics represents a risk to people’s health because the manufacturing, handling and storage conditions are unknown. Its safety, quality and effectiveness are not guaranteed.
He recommended that the general population, health professionals, distributors and pharmacies always verify that the lot numbers and expiration dates match on the packaging of any product.
Likewise, if there are doubts about the originality of a product, it is necessary to contact the holder of the health registration.
If the product is identified with the indicated characteristics, it should not be purchased and if there is information about its possible marketing, people can make the corresponding health complaint online at www.tramiteselectronicos03.cofepris.gob.mx or to the telephone number 800 033 5050.
Also, if the counterfeit biological was applied and the patient has any adverse reaction or discomfort, they must report it at the following electronic link: www.primaryreporting.who-umc.org or to email: farmacovigilancia@cofepris.gob.mx
2023-09-10 21:06:18
#Cofepris #alert #counterfeit #Hepatitis #vaccine
