The Food and Drug Administration (FDA), in coordination with Aurora provincial authorities, uncovered suspected counterfeit anti-rabies vaccines during an operation at several drugstores located near Aurora Memorial Hospital.
In a statement, the FDA said its Field Regulatory Operations Office–North Luzon Cluster conducted the inspection following the rabies-related death of an eight-year-old child.
On Wednesday, the agency carried out product tracing activities in San Isidro, Nueva Ecija, where the alleged distributor was found to have committed multiple violations.
Among the violations cited were the failure to present distribution records establishing the source of the anti-rabies vaccines and the lack 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, referring to the shop where the suspected counterfeit vaccine was discovered.
The agency also found that other drugstores with valid FDA Licenses to Operate were dispensing vaccines despite lacking authorization to engage in vaccine dispensing activities.
In addition, inspectors documented critical cold chain violations, including the storage of vaccines in household refrigerators alongside non-pharmaceutical products, practices that may compromise vaccine safety, quality, and efficacy, according to the FDA.
