NAFDAC Recalls Eye drops Causing Permanent Loss of Vision

The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians to the recalled Ezricare and Delsam Pharma Artificial Tears eye drops.

The recall is detailed in a public alert with No: 008/2023 dated Sunday and signed by NAFDAC Director-General, Prof. Mojisola Adeyeye in Abuja. Prof. Adeyeye said the eye drop was recalled in February due to suspected contamination with pseudomonas aeruginosa, a highly resistant bacterium.

According to her, the U.S. Centers for Disease Control (CDC) has reported 68 patients in 16 states with health problems caused by the bacteria, including eye infection, since the recall. Other problems associated with the eye drop were permanent loss of vision, surgical removal of eyeballs, and a case of death with a “bloodstream infection.”

Prof. Adeyeye said that laboratory testing recognized the bacteria in opened Ezricare bottles from multiple sources according to the CDC. She specified that unopened bottles are currently being examined to check whether contamination occurred during manufacturing.

Pseudomonas is a type of bacteria (germ) that is found frequently in the environment, like in soil and in water. The bacteria that most often causes infections in humans is called Pseudomonas aeruginosa, which can cause infections in the blood, lungs, or other parts of the body after surgery.

“Signs of infection include yellow, green, or clear discharge from the eye, discomfort or pain, redness, blurry vision, and increased sensitivity to light. Artificial tears (carboxymethylcellulose sodium), Lubricant Eye Drops are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.”

“Although the products are not in the NAFDAC database, importers, distributors, retailers, and consumers are therefore advised to exercise caution and vigilance within the supply chain. Importation, distribution, sale and use of the above-mentioned products must be obtained from authorized/licensed suppliers.

“The products’ authenticity and physical condition should be carefully checked. Members of the public in possession of the above-listed products are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.”

She advised anyone who may have used these products or suffered any adverse reaction/event after use to seek immediate medical attention. Prof. Adeyeye also advised healthcare professionals and consumers to report any suspicion or adverse drug reaction caused by substandard and falsified medicines to the nearest NAFDAC office.

“The public is urged to report any adverse effect to NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.”