Text on bottle box of Delsam Pharma’s Artificial Tears Lubricant Eye Drops
FDA
The eye drop recall that takes two brands of artificial tears off the market is the latest development in what the CDC calls an outbreak of “extremely drug-resistant” bacteria in Florida, New York, Texas, California and eight other states.
Here’s what you need to know from the CDC and the FDA.
What eye drops are recalled?
Global Pharma Healthcare recalled all lots, all expiration dates of Lubricant Eye Drops (Sodium Carboxymethylcellulose) from EzriCare and Delsam Pharma, which were sold over the internet.
EzriCare artificial tears have NDC code No. 79503-0101-15 and UPC code 3 79503 10115 7.
Delsam Pharma artificial tears have NDC No. 72570-121-15 and UPC code 72570-0121-15.
What is the problem with these artificial tears? “The use of contaminated artificial tears may result in the risk of eye infections that could result in blindness,” reads the risk statement in the recall notice written by Global Pharma and published by the FDA.
The CDC says there is an outbreak of “extremely drug-resistant Pseudomonas aeruginosa” that has affected 55 people in California, Florida, Texas, New York, Colorado, Connecticut, New Jersey, New Mexico, Nevada, Utah, Washington, and Wisconsin. . Of those 55, 35 people were in four groups of health centers. The consequences have included hospitalization, infection of the cornea resulting in total loss of vision, and death from a bloodstream infection.
“Most of the patients reported using artificial tears,” the CDC said. “Patients reported more than 10 brands of artificial tears, with some patients using multiple brands. Most of the patients who used artificial tears reported using EzriCare Artificial Tears, an over-the-counter product with no preservatives packaged in multi-dose vials. CDC laboratory testing identified the presence of the outbreak strain in opened bottles of EzriCare with different lot numbers collected in two states.”
What should you do now?
Stop using the drops and return them to the place of purchase for a full refund.
If you have questions about the EzriCare withdrawal, please call Aru Pharma at 518-738-7602 or email a[email protected], Monday through Friday, 11 am to 4 pm EST.
If you have questions about the Delsam recall, please call Delsam at 866-826-1309 or email d[email protected], Monday through Friday, 11 am to 4 pm EST.
If you have had any medical problems from this or any other medicine, consult your doctor first. Then, report it to the FDA through its MedWatch Adverse Events page or by completing a form that you can get by calling 800-332-1088.
Source: El Nuevo Herald
