FDA warns public vs. five unregistered medical products

Published February 7, 2021, 3:12 PM

by Analou de Vera

The Food and Drug Administration (FDA) has warned the public against the use and purchase of five unregistered drug products, saying that they may pose danger or injury to people’s health. 

(FDA/ MANILA BULLETIN)

In its  advisory 2021-0185, the  FDA said the following products did not undergo its evaluation: 

  • OTC Nanhai® Fufang Ku Shen Shui Ang Sunan
  • San-OTC 999® Yanyan Pian
  • OTC Fuke Qianjin Pian
  • Kaiherong®
  • DUB® Glucose Injection 5% 250 ml

“FDA Post-Marketing Surveillance activities have verified that the above mentioned drug products have not gone through the registration process of the agency and have not been issued with proper authorization in the form of Certificate Product Registration,” the FDA said. 

“Therefore, consumption of such violative products may pose potential danger or injury to health,” it added. 

The FDA called on concerned establishments not to distribute the unregistered products until they have already secured appropriate authorization from the agency.

“Otherwise, regulatory actions and sanctions shall be strictly pursued,” it warned. 

It reminded that Republic Act No. 9177, otherwise known as the “Food and Drug Administration Act of 2009 prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising, or sponsorship of health products without authorization from FDA.

Moreover, the FDA urged local government units (LGUs)  and other law enforcement agencies to ensure that these products “are not sold or made available in their localities or areas of jurisdiction.”

 
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