FDA seizes suspected counterfeit rabies vaccines in Aurora after child's death
By Jel Santos
The Food and Drug Administration (FDA) seized suspected counterfeit anti-rabies vaccines during an enforcement operation in Aurora conducted following the rabies-related death of an eight-year-old patient.
The agency identified the suspected counterfeit vaccines as “Equirab,” with batch numbers flagged under FDA Advisory No. 2025-1415.
In coordination with the local government of Aurora, the FDA inspected drugstores near Aurora Memorial Hospital on Tuesday, Feb. 10, where anti-rabies vaccines were reportedly purchased.
FDA’s regulatory and enforcement teams uncovered violations involving the sale, handling, and storage of anti-rabies vaccines.
According to the FDA, the establishment selling “Equirab” failed to present valid procurement and distribution documents to establish product authenticity and traceability.
“Other drugstores with valid FDA Licenses to Operate were also found dispensing vaccines despite lacking authorization to engage in vaccine dispensing activities,” it added.
As such, the FDA said it documented critical cold chain violations, including the storage of vaccines in household refrigerators together with non-pharmaceutical products, which may compromise vaccine safety, quality, and efficacy.
The agency noted that all vaccine stocks were immediately secured and sealed for product verification and regulatory proceedings, with those bearing batch numbers flagged under FDA Advisory No. 2025-1415 seized and confiscated.
The FDA said product traceability operations were conducted the following day, Feb. 11, in Alua, San Isidro, Nueva Ecija.
“The identified distributor was found to have committed multiple violations, including 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,” it said.
The FDA warned that counterfeit or improperly stored vaccines could pose serious health risks and may result in treatment failure, severe complications, or even death.