FDA flags fake rabies shots sold in Baler
The Food and Drug Administration (FDA) has called on the public to buy vaccines only from authorized establishments after several drug stores in Baler, Aurora, were found to be selling antirabies shots believed to be counterfeit.
In a statement on Wednesday, the FDA said it conducted an enforcement operation on Feb. 10, inspecting drug stores near Aurora Memorial Hospital, following the death of an 8-year-old patient due to rabies.
The parents of the child reportedly bought the antirabies vaccine from a drug store in the area, although the FDA said it could not confirm if the suspected fake shot caused the death of the patient.
During the inspection, the FDA said that regulatory and enforcement teams discovered what they suspected were counterfeit antirabies vaccines identified as “Equirab.” The shots bore batch numbers flagged in an FDA advisory issued last year.
The FDA said the drug store selling the suspicious vaccines failed to present valid procurement and distribution documents that would allow authorities to establish product authenticity and traceability.
Unauthorized vendors
On the other hand, the FDA found out that other accredited drug stores were selling vaccines despite the lack of authorization.
It also noted improper storage procedures for vaccines in some of the drug stores, with some stored in household refrigerators together with nonpharmaceutical products.
According to the FDA, improper storage may compromise vaccine safety, quality and efficacy.
It said it immediately secured and sealed all the vaccine stocks for verification and further regulatory action, with the suspected counterfeit products seized and confiscated.
The following day, on Feb. 11, the FDA tracked down the distributor of the products at Barangay Alua in San Isidro, Nueva Ecija. The person concerned failed to present distribution records establishing the source of the antirabies vaccines.
The FDA urged the public to buy vaccines only from authorized establishments and to have these administered by qualified health-care professionals. It stressed that the use of counterfeit or improperly stored vaccines poses serious health risks and can lead to treatment failure or death.
The FDA also urged the public to immediately report suspicious products, illegal sales and improper vaccine storage by sending an email to ereport@fda.gov.ph.
