FDA warned “the use of unregistered eye drops may result in inflammation, irritation, infection of the eye or loss of vision.” - PH Trending

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Sunday, 6 September 2015

FDA warned “the use of unregistered eye drops may result in inflammation, irritation, infection of the eye or loss of vision.”


Lists of unregistered eye drops products that pose potential danger or injury to the consuming public issued by FDA a several advisories banning of sale and use.

  1. Carboxymethyl Cellulose Sodium + Glycerin (Tearbright Plus) 10 mL Eye Drops.
  2. CMD Eye drop 15 ml.
  3. Gatifloxacin + Prednisolone Acetate (Gatsun-P) 5 mL Eye Drops.
  4. Latanoprost Ophthalmic Solution (Latanobright) Eye Drops 2.5 mL.
  5. Moxifloxacin Hydrochloride (Moxibright) 5 mL Eye Drops
  6. Moxifloxacin Hydrochloride + Dexamethasone Sodium Phosphate (Moxibright DM) 5 mL Eye Drops.
  7. Moxifloxacin Hydrochloride (Occumox) 5 mL Eye Drops.
  8. Naphazoline Hydrochloride + Zinc Sulphate + Chlorpheniramine Maleate (Naphabright) Eye Drops 10 mL.
  9. Olopatadine Hydrochloride (Patabright) Eye Drops 5 m
  10. Potassium Iodide + Calcium Chloride (Catabright Plus) Eye Drops 5 mL.


Violation. Violation of Republic Act No. 9711 or the Food and Drug Administration Act of 2009
Imported. Unregistered eye drops above lists are mostly imported from India.
Alert. FDA warned “the use of unregistered eye drops may result in inflammation, irritation, infection of the eye or loss of vision.”

Case Issue. Unregistered eye drop product costing PhP100 from a self-styled “eye doctor” who does his business at the sidewalk of Rizal Avenue in Santa Cruz, Manila.

The name of product is Herbal Eye Drop Wild Sampaguita Extract that cleanses and removes bacteria from the eyes packed in a small plastic bottle with blue cap and label. But Thony Dizon, Coordinator of the EcoWaste Coalition’s Project Protect mentionoing the “Herbal Eye Drop Wild Sampaguita Extract” as an example marked as red flags that vigilant consumers should know about: no manufacturer and/or importer information, no ingredients’ list, no instruction on usage no precautionary statement and no information was provided on the product’s date of manufacturing and lot number. Even though there is a label indicated “BFAD No. FR 40738,” the product as per FDA website is not registered.

Solution. The EcoWaste Coalition on Saturday went drug store-hopping in Rizal Avenue near Jose Reyes Memorial Hospital in search of the above unregistered eye drops, and was relieved not to find them being sold in the area.

Reference:


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