Public Alert No:008/2023 – Alert on Recalled artificial tears eye drops linked to death, blindness and eyeball removals in US
March 22, 2023,
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public that Global Pharma Healthcare have recalled EzriCare and Delsam Pharma Artificial Tears eye drops early in February. The recall of the preservative-free eye drops were due to suspected contamination with pseudomonas aeruginosa, a highly resistant bacteria.
Since the recall, the US Centre for Disease Control (CDC) has reported 68 patients across 16 states who have suffered health problems from the bacteria, including eye infections, permanent loss of vision, surgical removal of eyeballs and a case of death with a “bloodstream infection” had also been reported.
Laboratory testing identified the bacteria in opened EzriCare bottles from multiple sources, according to the CDC. Unopened bottles are currently being examined to check whether contamination occurred during manufacturing.
Pseudomonas is a type of bacteria (germ) that is found commonly in the environment, like in soil and in water. Of the many different types of Pseudomonas, the one that most often causes infections in humans is called Pseudomonas aeruginosa, which can cause infections in the blood, lungs (pneumonia), 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.
The details of the products are as follows;
Product Manufacturer: Global Pharma Healthcare, Tamilnadu, India.
Brand Name: EzriCare & Delsam Pharma
Product Description: Artificial Tears Lubricant Eye Drops
Affected Lots: All lots within expiry
Although the products are not in NAFDAC database, importers, distributors, retailers and consumers are therefore advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the above mentioned products. All medical 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.
If you have batches of the products, please DO NOT use them. If you, or someone you know, have used these products, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of adverse drug reaction, substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: firstname.lastname@example.org
Similarly, Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal product through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on email@example.com