GHANA — The Food and Drugs Authority (FDA) has issued a warning to the general public regarding the use of two brands of contaminated eye drops that are currently on the market.
The two products in question are ‘Ezricare artificial tears’ and ‘Delsam Pharma’s artificial tears’, both of which are produced by Global Pharma.
The FDA has reported that the manufacturers have voluntarily recalled the products after they were found to contain the drug-resistant bacteria, Pseudomonas aeruginosa.
The FDA has expressed concern over the products as they have been linked to three deaths and vision loss in eight patients.
The regulatory body has stated that the contaminated eye drops are not registered with the Ghana FDA and therefore should not be available on the Ghanaian market.
The FDA has advised the public to immediately stop using the recalled products if they are in possession of them through other means and submit them to any of the FDA offices nationwide.
Individuals who may have unknowingly used these recalled products and are experiencing symptoms such as yellow, green, or clear discharge from the eye, eye pain or discomfort, redness, increased sensitivity to light, and blurred vision are advised to seek professional care immediately.
The FDA has reassured the public that it is taking all necessary measures to ensure that only safe and effective medical products are available in Ghana.
The regulatory body has emphasized the importance of ensuring that medical products are registered with the FDA before they are made available on the market.
Already the US Centre for Disease Control and Prevention has classified the incident as an outbreak and the manufacturer of the two types of eyedrops, Global Pharma, has already recalled the products from the US markets.
The FDA has issued a warning about Delsam Pharma’s Artificial Eye Ointment, due to concerns of bacterial contamination.
The same manufacturer had already recalled two other eye products earlier this year, after an outbreak of a rare and drug-resistant bacteria, Pseudomonas aeruginosa, which hospitalized and blinded some patients.
The CDC has identified 58 patients, and at least 16 were hospitalized, five were permanently blinded, and one died after the infection spread to their bloodstream.
Most cases were linked to online purchases before the recall, but one patient reportedly bought the product from Costco.
Despite the recall, the Delsam Pharma Artificial Eye Ointment, like the EzriCare products earlier, is still being sold on several online platforms, including Amazon, where it is ranked among the top 50 best-selling “dry eye relief” products.
The reason behind the FDA’s decision to expand its warning is not yet known, as the regulator declined to provide any additional details regarding the “ongoing matter.”
Global Pharma, the Indian-based company that manufactures these products, was subjected to an unannounced inspection by Indian authorities earlier this month, according to NDTV, a local news outlet.
Since then, the company has suspended production of the Delsam Pharma and EzriCare products.
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