FDA advises public to be vigilant against the purchase of an unregistered drug product

Published June 7, 2018, 6:35 PM

by Roel Tibay

By Analou De Vera

Health authorities advised the consumers to be vigilant against the purchase of an unregistered drug product called “Antine Diclofenac Sodium Sustained Release Capsule.”

FDA logo (Google image) Manila Bulletin
FDA logo (Google image) Manila Bulletin

In an advisory, the Food and Drug Administration (FDA) said its postmarketing surveillance confirmed that the said product had not gone through its registration and evaluation process.

“Since this unregistered drug product has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety,” the agency stated.

“The consumption of such violative product may pose potential danger or injury if administered,” added the FDA.

The agency advised the public not to purchase the said product and “be vigilant against drug products that might not be duly registered with the FDA.”

The FDA also directed the establishments not to advertise, sell or distribute the product “until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.”

Local government units were also advised to ensure if it continued to be sold or made available in their localities.