The Food and Drug Administration (FDA) advises the public on the ongoing distribution and/or selling of the following unregistered drug product:
- Lianhua Qingwen Jiaonang with Chinese Characters
As per continuing post-marketing surveillance, there is still incessant sale and distribution even through social media platforms, such as Facebook, of Lianhua Qingwen Jiaonang with Chinese characters, which were verified as unregistered by the FDA. Please be informed that only the Lianhua Qingwen Jiaonang with English text and the following details was issued with a Certificate of Product Registration (CPR) and approved to be sold/marketed in the Philippines:
|MANUFACTURER||Shijiazhuang Yiling Pharmaceutical Co., Ltd. –
238 Tianshan Street, High-Tech Area, Shijiazhuang Hebei Province, China
|IMPORTER||Phil. Archipelago International Trading Corp. – Limtuaco Bldg., 1830 EDSA Apolonio Samson, Balintawak, Quezon City|
|CLASSIFICATION||Prescription Drug (Rx)|
Thus, the Agency cannot guarantee the quality and safety of the product with the Chinese text due to these have not undergone evaluation by the FDA and these came from unlicensed sources or establishments. The consumption of such violative product may pose potential danger or injury if administered.
Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising, or sponsorship of health products without proper authorization from FDA is prohibited.
All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product, otherwise, regulatory actions and sanctions shall be strictly pursued.
Therefore, all Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that this unregistered drug product is not continually sold, distributed, or made available in their localities or areas of jurisdiction.
For more information and inquiries, please e-mail us at [email protected] To report continual sale or distribution of the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.
Dissemination of the information to all concerned is highly requested.