The company Pharmedica USA voluntarily recalled several lots of eye drops put into circulation. The company, supported in a statement by the FDA (Food and Drug Administration), said the recall is due to insufficient sterilization of its Purely Soothing product. According to the FDA, this puts customers at risk for eye infections, which can lead to blindness.
This saline solution, with 15% methylsulfonylmethane (MSM), is marketed in large supermarkets to treat eye swelling or infection. Pharmedica USA's decision was made after the CDC (Centers for Disease Control and Prevention) stated that cases of severe pseudomonas aeruginosa infection have increased in the past few months. The CDC says it believes the outbreak is related to the use of up to 10 brands of artificial tears.
Purely Soothing 15% MSM Drops by Pharmedica USA: Recall - Due to Non-Sterility https://t.co/pEX6lUS4Aa pic.twitter.com/vBC0tnOzjN
— US FDA MedWatch (@FDAMedWatch) March 7, 2023
According to the alert issued by the FDA and the CDC, 60 people have been affected by this outbreak in 12 different states. Pharmedica USA is not the first company to recall its products in the last few weeks. EzriCare and Delsam Pharma have also recalled some of their products.
"Pharmedica USA LLC advises customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing/returning to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification," the FDA said in its statement.
According to the FDA, affected lots are identifiable by the following codes visible on the bottom of the packages. LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9.
The CDC urges people to seek medical attention if they have used any of these types of drops and if they are experiencing symptoms such as the following: yellow, green or clear discharge from the eye; eye pain or discomfort; redness of the eye or eyelid; sensation that there is something in the eye, increased sensitivity to light or blurred vision.
