FDA halts sale of Family Care Digital Thermometer

The Food and Drug Administration (FDA) ordered all its Regional Field Offices and Regulatory Enforcement Units to stop the sale of the unregistered Family Care Digital Thermometer.

The FDA explained that the Family Care™ Digital Thermometer did not have a Certificate of Product Registration (CPR), based on their post-marketing surveillance.

The agency could thus not vouch for the quality and safety of the digital thermometer since it had not undergone their evaluation process.

“All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued,” FDA said in an advisory on Friday.

Under the Republic Act No. 9711, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization were prohibited.

“In light of the foregoing, the public is advised not to purchase the violative product in the market,” the FDA emphasized.

Meanwhile, the FDA also called on the Bureau of Customs (BOC) to restrain the entry of the product. — Joviland Rita/DVM, GMA News