The Food and Drug Administration (FDA) on Friday cautioned the public against purchasing and using unregistered drug products.
In an advisory, the FDA warned the public against the purchase and use of the following products: Huons Hycomin Inj. (Hydroxocobalamin) 5 mg/ 2 mL x 50 Ampoules, Huons Pyridoxine HCl Inj. Vitamin B 50 mg/mL 50 Ampoules, Human Placenta Hydrolysate Laennec Inj. 2 mL x 50 Ampoules, DAI HAN Epinephrine inj. (Adrenaline Inj. K.P.) 1mL x 50 Ampoules, Huons Vitamo Inj. (D-Panthenol) 500 mg / 2 mL Injection 2mL x 50 Ampoules, Miao Relieves Headache Qu Feng You 10 mL, Miao Qu Feng You Relieves Headache 10 mL, Himalaya® Koflet® Cough Syrup 100 mL, ZANDU Nityam Ayurvedic Vati Castor Oil Shakti Tablet, SHETH BROTHERS Ayurvedic Kayam® Tablet, INTAS Sildenafil Citrate Tablets I.P. 100 mg Intagra 100, SHIN POONG Antispasmodic Eukinetic Agent Tiram Injection Tiropramide HCL 3 mL x 50 Ampoules for I.M., I.V., Ethical WonderTox® Inj Clostridium Botulinum Toxin Type A 100 units x 1 vial, Ethical WonderTox® Inj Clostridium Botulinum Toxin Type A 200 units x 1 vial, Gangnam booster A Human adipose stromal cell 3 mL B Polycaprolactone 2 mL, Gangnam booster A human adipose stromal cell 3 mL, and Gangnam booster B Polycaprolactone 2 mL.
It also warned the public of the following products: Ethical LIZTOX® Inj. Clostridium Botulinum Toxin Type A 100 Units, SK 50mg, DongKwang Roxithromycin Tablet, Golden City Brand China Liu Tam So, HKC-14197, Myda-B Strong Cough Capsules HKCP-106365, Houns Ethical Ginkobal Inj. (Ginkgo Leaf Dried Extract) 17.5 mg/5mL, LG Chem Declage Inj. Recombinant hGH (Somatropin) 3mg x 1 vial, GC Meganesium inj. 10% Magnesium Sulfate Hydrate 5mL x 50 Ampoules, HAWON Haprokin inj. Frusultiamine Hydrochloride 10 mL, GC Fursultamin Inj. Fursultiamine Hydrochloride 50mg/10mL ampoule, OTC Gan Kang® Compound Paracetamol and Amantadine Hydrochloride Tablets, OTC Jianwei Xiaoshi Pian, OTC Erythromycin Ointment, OTC Huoxiang Zhengqi Shui.
Moreover, the FDA also warned of the following products: Samil Forus 5g Ophthalmic Ointment, Acnon 13 g, Dongkook Madecassol Centella asiatica from nature 8g ointment, Acetaminophen Capsules Spasmo-Proxyvon® Plus 8’s, Baidyanath Asli Ayurved Prost Aid Tablet 50’s, HimalayaTM Bresol®-NS Saline Nasal Solution 10 ml, Intas Sildenafil Citrate Tablets I.P. 50 mg Intagra 50 1 x 4 tablet, Jinling Sanshedan Chuanbei Ye 10 mL Vial 12’s, Taisho Analgesic Balm Counterpain® Methyl Salicylate, Levomenthol, Eugenol 30 grams, Korean Red Ginseng Powder Capsule 100’s, Cefradine Capsules 0.25 g, Rengong Niuhuang Jiaxiaozuo Jiaonang Capsule, OTC Erythromycin Ointment, OTC Fenbid Ibuprofen Sustained-release Capsules.
"FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration," it said.
"Thus, the Agency cannot guarantee their quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health."
The FDA reminded the public that the manufacture, importation, exportation, sale, distribution, transfer, promotion, advertising, or sponsorship of health products without proper authorization from the agency is prohibited.
It also warned all concerned establishments and/or entities not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorizations, otherwise, regulatory actions and sanctions will be pursued by the FDA.
"Always check if the products are registered with the FDA by using the FDA Verification Portal feature accessible at https://verification.fda.gov.ph," the FDA said.
It 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 jurisdictions.