FDA warns public vs buying, using 20 unregistered medicines
MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public against purchasing and using 20 unregistered drug products circulating in the market, mostly labeled in a foreign language or dubbed as “traditional Chinese medicine,” due to potential health risks.
In four separate advisories released January 13, the FDA identified the enumerated products below as unlisted or unregistered because these items did not undergo government evaluation and registration to guarantee their safety and efficacy:
- A Qi Mei Su Fen San Pian
- OTC Anshenbunaoye
- Erythromycin Estolate Tablets
- OTC Huoxiang Zhengqi Shui
- OTC [Label in Foreign Language]
- OTC Guo Guang® Z50020601 [Label in Foreign Language]
- OTC Z34020127 [Label in Foreign Language]
- SPH H31020387 [Label in Foreign Language]
- GB15979 12g [Label in foreign Language]
- CISEN® H37021822 250ml [Label in Foreign Language]
- OTC Bei® Kangbingdukoufuye
- Levofloxacin Hydrochloride Tablets 0.1g
- CISEN® Levofloxacin Lactate and Sodium Chloride Injection 100ml:0.2g
- SINE® Lincomycin Hydrochloride Injection 2ml : 0.6g
- OTC Musk Hemorrhoids Ointment
- CISEN® H37021756 5% 250ml 12.5g [Label in Foreign Language]
- CISEN® H37021825 5% 500ml:25g[Label in Foreign Language]
- Jinkui Shenqi Wan
- Josamycin Tablets 0.2g
- OTC Z44022627 [Label in Foreign Language]
The regulator stressed that no Product Notification Certificates have been issued to any of the above-listed medicines.
“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,” FDA warned.
“All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued,” it added.
FDA asked all local government units and law enforcement agencies to make sure these products would not be sold in their respective areas of jurisdiction.
It likewise advised the public to report continuous sale or distribution of unregistered health products.
Traditional Chinese medicine
Some of the unregistered drugs on the list were described and labeled online as “traditional Chinese medicine.”
In a 2019 advisory posted by the Therapeutic Goods Administration (TGA) of the Australian Government’s Department of Health, batches of a certain brand of Jin Gui Shen Qi Wan (金匮肾气丸) were recalled or removed from the market “due to potential toxicity.”
“Jin Gui Shen Qi Wan pills are a complementary medicine used in traditional Chinese medicine, and are marketed to help or treat various complaints including mild bronchitis,” the TGA said on its website.
Some brands of Musk Hemorrhoids Ointment being sold overseas are also labeled as traditional Chinese medicine.
