FDA finds suspected counterfeit anti-rabies vaccines at drugstore in Aurora

The Food and Drug Administration and Aurora provincial authorities found suspected counterfeit anti-rabies vaccines in an operation at drugstores near the Aurora Memorial Hospital.

In a statement, the FDA said its Field Regulatory Operations Office-North Luzon Cluster conducted the operation on Tuesday in connection with the rabies-related death of an eight-year-old.

The FDA conducted product tracing on Wednesday in San Isidro, Nueva Ecija, where the alleged distributor was found to have committed multiple violations.

These include failure to present distribution records establishing the source of the anti-rabies vaccines, and absence of appropriate storage equipment required for high-risk products such as biologicals and vaccines.

“The establishment failed to present valid procurement and distribution documents to establish product authenticity and traceability,” the FDA said in a statement regarding the shop where the alleged counterfeit vaccine was found. 

“Other drugstores with valid FDA Licenses to Operate were also found dispensing vaccines despite lacking authorization to engage in vaccine dispensing activities,” it added.

“Critical cold chain violations were likewise documented, including the storage of vaccines in household refrigerators together with non-pharmaceutical products, which may compromise vaccine safety, quality, and efficacy,” the FDA said. –NB, GMA Integrated News