National Institute of Hygiene issued a health alert for counterfeit batches of oncological drug

Published at: 23/09/2026 10:08 PM

The Rafael Rangel National Institute of Hygiene (INHRR) alerted health professionals and the general public to the illegal commercialization of units of the oncological drug OPDIVO (nivolumab) 10 mg/mL in Venezuela.

On its social networks, the agency noted that the technical investigation made it possible to identify irregularities in two batches of the drug: ACT5594 and ACW3070, whose origin and characteristics do not correspond to products authorized for sale in the country.

The first case corresponds to batch ACT5594, with a manufacturing date of March 2024 and due in February 2027.

According to the INHRR, the original batch manufactured by Bristol Myers Squib b was intended exclusively for the Colombian market in a 100 mg/10 mL presentation, while the units detected in Venezuela have a package corresponding to a 40 mg/4 mL presentation.

The technical evaluation also identified alterations in the labeling, including differences in concentration and volume, as well as variations in graphic materials and colors of the labels compared to the original products.

The agency also indicated that these units entered the country through unauthorized channels and warned that, since it is a counterfeit product, it is not possible to guarantee its composition, sterility or therapeutic effectiveness.

The second alert corresponds to batch ACW3070, manufactured in October 2024 and with an expiration date in September 2027, in a 100 mg/10 mL presentation.

The investigation determined that the units entered the country illegally through packages from Cúcuta, Colombia.

The INHRR noted that Bristol Myers Squibb, the parent company, confirmed that the original lot corresponds to the Colombian market, so the product located in Venezuela was classified as a probable counterfeit.

Another element identified on the packaging is the legend “INSTITUTIONAL USE”, which, according to the research, indicates that the products belonged to special public programs in other countries and would have been diverted irregularly.

The institute warned that, due to their unknown origin and the absence of health control, the origin, composition, sterility or therapeutic effectiveness of these units cannot be guaranteed, which represents a risk for patients.

Given these results, the Rafael Rangel National Institute of Hygiene urged not to purchase or administer lots ACT5594 and ACW3070 of OPDIVO (nivolumab) under any circumstances.

The agency recalled that the genuine product authorized for distribution in Venezuela is sold only through the pharmacies of the BADAN Foundation, so it recommended avoiding purchases through intermediaries, unauthorized establishments or digital platforms.

He also asked to report the commercialization of these lots in physical stores or social media accounts through the email alertasinhrr@gmail.com.