FDA eyes 'violative' anti-rabies vaccine in Aurora death

FDA eyes 'violative' anti-rabies vaccine in Aurora death
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THE Food and Drug Administration (FDA) is looking at the possibility of a counterfeit anti-rabies vaccine being related to the death of an eight-year-old in Aurora recently.

In a statement, the FDA said it conducted an urgent enforcement operation following the recent rabies-related death of an eight-year-old patient.

"The operation targeted drugstores located near the Aurora Memorial Hospital where anti-rabies vaccines were reportedly purchased," the FDA.

It said the operation found several violations in drugstores particularly those near the Aurora Memorial Hospital.

"During the inspection, FDA regulatory and enforcement teams uncovered violations involving the sale, handling, and storage of anti-rabies vaccines," said the FDA.

"The FDA immediately secured and sealed all vaccine stocks for product verification and further regulatory action," it added.

The agency said it discovered suspected counterfeit anti-rabies vaccines identified as “Equirab" while bearing batch numbers flagged under FDA Advisory No. 2025-1415 even as the establishment failed to present valid procurement and distribution documents to establish product authenticity and traceability.

It also noted that there are drugstores with valid FDA licenses to operate found dispensing vaccines despite lacking authorization to engage in vaccine dispensing activities.

The FDA said critical cold chain violations, including the storage of vaccines in household refrigerators together with non-pharmaceutical products, were also documented.

"Counterfeit or improperly stored vaccines pose serious health risks and may lead to treatment failure, severe complications, or death," said the FDA. (Anton Banal/SunStar Philippines)

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