A pharmaceutical company has issued a voluntary recall of eye drops due to sterility issues amid rising reports of bacterial infections linked to similar products.
Pharmedica USA LLC has issued a recall for its product Purely Soothing, 15% MSM Drops due to “non-sterility,” warning consumers the “use of contaminated eye drops can result in the risk of eye infections that could result in blindness,” the FDA announced.
Though no infections have been linked to Pharmedica USA LLC’s eye drops, their recall comes amid a widespread bacterial outbreak linked to similar products developed by the Indian company Global Pharma Healthcare. In February, EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears were recalled after health officials linked the drops to a drug-resistant strain of bacteria in 12 states that left some consumers blinded and led to the death of another.
The latest recalled eye drops were sold worldwide through trade shows and via online marketplaces like Amazon. https://t.co/yE13YxhveT
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That recall was expanded later in February to include another product from the company, Delsam Pharma’s Artificial Eye Ointment, after the bacterial infections spread to another state.
During initial investigations, researchers discovered the culprit behind the infections was a bacteria known as Pseudomonas aeruginosa, a strain that had never previously been reported in the United States. The bacteria was reportedly detected in open bottles of EzriCare Artificial Tears. (RELATED: Company Recalls 145,000 Cans Of Baby Formula Over Potentially Dangerous Bacteria)
The Centers for Disease Control (CDC) announced Feb. 21 that it was working with the FDA as well as state and local governments to investigate the outbreak which now has affected 13 states and 58 patients.
“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 Pharmedica USA LLC immediately or confirm that the product has been disposed of With proper verification,” the FDA announced.