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Pharmedica USA LLC is recalling two lots of its Purely Soothing, 15 percent MSM Drops due to a non-sterility problem, according to the warning notice posted by the FDA. Methylsulfonylmethane, or MSM, is found in a number of supplements and is touted as a treatment for a range of health issues.
“Use of contaminated eye drops can result in the risk of eye infections that could result in blindness,” the March 3 notice said. “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,” it also said.
The company said in the notice that it has not 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 due to 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.
In February, both the Centers for Disease Control and Prevention (CDC) and FDA told consumers and medical providers not to use or purchase Delsam Pharma’s Artificial Eye Ointment or EzriCare’s and Delsam Pharma’s artificial tears products over potential contaminants.
“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.”
According to a CDC health alert issued March 1, about 61 people have been infected with a drug-resistant strain of the Pseudomonas aeruginosa bacteria across about a dozen U.S. states. Cases in California, Colorado, Connecticut, Florida, Illinois, New Jersey, New Mexico, New York, Nevada, Texas, Utah, and Washington have been identified.
“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.
The bacteria, commonly found in soil and water, poses the most risk to people using ventilators or catheters, or among those with wounds from burns or surgery, the agency says. Symptoms vary greatly depending on the type of infection.
The majority of patients told the CDC that they used artificial tears, noting more than 10 different brands. But lab testing performed by the CDC found the presence of the Pseudomonas aeruginosa bacteria in some EzriCare bottles from several lots.
In response, EzriCare said it had “no role in the formulation” or manufacturing of the eye drops, according to a February statement. “As of today, we are not aware of any testing that definitively links the Pseudomonas aeruginosa outbreak to EzriCare Artificial Tears,” the statement added. “Nonetheless, we immediately took action to stop any further distribution or sale of EzriCare Artificial Tears. To the greatest extent possible, we have been contacting customers to advise them against continued use of the product.”
By Jack Phillips