FDA issues warning against unregistered medicines, disinfectants, beauty products

The Food and Administration (FDA) issued a warning against the purchase and use of unregistered products, medicines, and disinfectants that may have potential hazards.

On Monday, FDA released a series of advisories for the that have no certificate of product registration and certificate of product notification, based on its post- surveillance  activities:

  • Cefdinir Capsules 0.1g
  • OTC YUNPENG® Compound Aluminum Hydroxide Tablets
  • OTC Eloson® Mometasone Furoate Cream 0.1% (5g:5mg)
  • OTC Terbinafine Hydrochloride Cream
  • Sanofi Clopidogrel Bisulfate Tablets (Plavix®) 75mg
  • OTC Calamine Lotion
  • OTC Cimetiden Tablets
  • Hydrogen Peroxide Disinfectant H2O2 100mL
  • OTC Berberine Hydrochloride Tablets
  • Tov Hair Color Wax
  • Christopher’s Perfume Our Version Of: Issey Miyaki Homme Sport For Men
  • Moist Skincare Papaya Whitening Lotion
  • Zenutrients Argan Nourishing Facial Wash
  • Loujene Non Acetone Enamel Remover
  • Mio Piccolo Tokyo Eyebrow Mascara
  • Mag Art Nail Forest Green

FDA issues warning against unregistered medicines, disinfectants, products

FDA warned consumers might experience from using products with ingredients that are not allowed to be part of a cosmetic product or from heavy metals contamination.

“The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, and organ failure,” it said.

The FDA’s Post-Marketing Surveillance (PMS) has proven that such drugs do not go through the Agency’s registration process and are not authorized according to the Certificate of Product Registration (CPR). As a result, the Agency cannot guarantee its quality, safety, and effectiveness. Therefore, the use of such illegal products can pose a health risk.

According to Republic Act No. 9711, or the Food and Drug Administration Act of 2009, the manufacture, importation, sale, distribution, transfer, promotion, advertising, or sponsorship of health products without proper authorization from the FDA is prohibited.

All establishments and/or entities are warned not to distribute such illegal products until they have been authorized. Competent punishment will be strictly enforced on violators.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are required to ensure that these products are not for sale or available in their jurisdictions.