FDA warns public vs. unregistered medical products, drugs

The Food and Drug Administration (FDA) has warned healthcare professionals and the public against the use and purchase of medical products found to be unnotified or without proper authorization and unregistered drugs.

In a series of advisories on Tuesday, the FDA said the following products were not notified and have not been issued a product notification certificate based on its post-marketing surveillance:

•     Disposable Face Mask 99% Bacteria Filtration Efficiency
•     Zhad Yang Medical Cotton Swabs

Meanwhile, FDA said the following drug products have not gone through the registration process and have not been issued with proper authorization or Certificate of Product Registration:

• Zithromax® Azithromycin For Suspension 0.1g
• OTC F® Z51020114 [Label in Foreign Language]
• KL® Sodium Chloride Injection 0.9% 500ml:4.5g
• OTC H20003790 [Label in Foreign Language]
• Xinshenghua Keli
• OTC Zhibai Dihuang Wan
• HUIFA® Zhisuningpian

Under Republic Act No. 9711 or the Food and Drug Administration Act of 2009, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of health products without the proper authorization is prohibited.

The FDA said since the unnotified and unregistered medical products and drugs have not gone through evaluation process, the agency cannot assure their quality and safety.

The agency also advised the public not to purchase and consume the following unregistered food products:

•     OBF Longanisa de Guinobatan Special Longganisa - Spicy | Special Longganisa - Regular
•     Pro-fit Berry Barley Premium Barley Drink, Net Wt. 225g (15g X 15 Sachets)
•     D’Barako Coffee in a Bag Puro Kapeng Barako, 13 Bags
•     First Vita Plus Lemon Grass Tea with Green Tea, Net Wt. 1.5g X 10 Sachets
•     Wild Organica Turmeric Powder
•     Dr. Wang Turmeric Coffee
•     L&P Calamansi Juice, Net Vol. 330ml
•     Laid's Special Chicharon - Spicy
•     Emy's Sweets and Pastries Tamarind - Salted
•     Emy's Sweets and Pastries Tamarind - Sweet
•     Goodtaste Pork Luncheon Meat, Net Wt. 397 grams (14 oz)
•     Charlyn's Special Miswa
•     Pabo Miswa, Net Wt. 200g
•     Maya Miswa, Net Wt. 200grams
•     Canciller's Food Products Special Pancit Canton, Net Wt. 250g

The FDA urged all concerned establishments not to distribute these products until they obtain authorization, otherwise, regulatory actions and sanctions will be pursued.

The FDA also requested all local government units and law enforcement agencies to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

Further, the agency asked the Bureau of Customs to restrain the entry of the unregistered products.—AOL, GMA News