The U.S. Food and Drug Administration (FDA) issued a notice that more eye drops are being recalled worldwide because of possible bacterial contamination.
“Use of contaminated eye drops can result in the risk of eye infections that could result in blindness,” the March 3 notice says. “Pharmedica USA LLC is advising customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification.”
The company said in the notice that it hasn’t received any reports of adverse events or illness connected to the eye drops, which were distributed and sold worldwide via “e-commerce and trade shows” such as Amazon Marketplace.
“The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles,” it said.
One batch of the recalled eye drops has lot number 2203PS01, is contained in 1-ounce bottles, and has a UPC of 7 31034 91379 9. The other recalled product has lot number 1808051, comes in half-ounce bottles, and has a UPC of 7 31034 91382 9. They both have eye dropper caps and white lids.
The notice comes following several recalls and health alerts because of potentially contaminated eye drops in recent months.
Apotex Corp. said on March 1 it initiated a voluntary recall for certain lots of Brimonidine Tartrate Ophthalmic Solution “out of an abundance of caution due to cracks that have developed in some of the units’ caps.” The problematic caps could affect the product’s sterility and increase the risk of adverse events, according to an FDA-posted notice.
“FDA recommended that Global Pharma recall Delsam Pharma’s Artificial Eye Ointment, and the firm agreed to initiate a recall,” said an updated statement from the FDA, issued in late February. The federal drug regulator also said it is “also now warning consumers and health care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination.”
“Using contaminated artificial tears increases the risk of eye infections that could result in blindness or death,” the FDA said earlier in February. “Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately.”
“These specimens were collected in both outpatient and inpatient healthcare settings,” said the CDC. “Patient outcomes include permanent vision loss resulting from ocular infection, hospitalization, and death of one patient with bloodstream infection.” It added that one person has died and there have been at least eight reports of vision loss.
In response, EzriCare said it had “no role in the formulation” or manufacturing of the eye drops, according to a February statement.