Public warned on batch of Rabipur anti-rabies vaccine without FDA approval

MANILA, Philippines—Health authorities have warned the public against the use of a specific batch of illegally imported Purified Chick Embryo Cell Rabies Vaccine (inactivated) 2.5 IU/mL.

In an advisory, the Food and Drug Administration (FDA) said that the Rabipur anti-rabies vaccine with batch number 2412 was found to be distributed in the Philippine market without FDA approval.

Rabipur is used for active immunization against rabies.

Batch 2412, however, has been found with safety risks and possible adverse health consequences, the FDA said.

PHOTO from fda.gov.ph

It noted that the product’s marketing authorization holder, Novartis Healthcare Philippines Inc., reported the batch to be “illegally imported from India.”

“Thus, proper handling of the product during shipment is not assured, compromising its potency that can result to treatment failure and even death,” the FDA said in an advisory.

The FDA advised consumers to buy only from FDA-licensed drug outlets and pharmacies and to demand official receipts.

It reminded drug outlets and pharmacies not to dispense, sell or use fake or unregistered or smuggled medicines peddled by unlicensed suppliers.

The FDA also advised drug outlets and pharmacies to demand official receipts from distributors and check the licenses to operate of the supplier and the certificate of product registration of the products they procure.

All FDA field inspectors were also ordered to monitor the medicines and seize counterfeited or smuggled or illegally imported medicines in the country.

The FDA urged consumers to report unregistered, counterfeit or smuggled medicine at [email protected].