The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered drug products:
- Lady Guada SALICYLIC ACID 25 mL
- Lady Guada TINCTURE OF BENZAL 15 mL
- Lady Guada OIL OF WINTER GREEN 25 mL
- Lady Guada Aceite De Manzanilla 30 mL
- Lady Guada EUCALYPTUS OIL 10 mL
- Lady Guada HYDROGEN PEROXIDE AGUA OXIGENADA SOLUTION USP XIV
The FDA has verified through Post-Marketing Surveillance that the abovementioned drug products are not registered and no Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as “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.
Since these unregistered drug products have not gone through evaluation process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative products may pose health risks to consumers.
In light of the foregoing, the public is advised not to purchase these violative products. Moreover, the public is advised to always check if a drug product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.
All concerned establishments are warned not to distribute the violative drug products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment and a CPR for the drug product.
All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.
For more information kindly contact the FDA Center for Drug Regulation and Research through e-mail at [email protected], or call (02) 809-5596.
To report any sale or distribution of unregistered drug product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.
Dissemination of this advisory to all concerned is hereby requested.