Some lots of a globally distributed eye drops may not fulfill the promise of its name.
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Two lots of Purely Soothing eye drops sold by online retailers and at trade shows have been recalled by Phoenix-based manufacturer Pharmedica USA.
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The lots of Purely Soothing, 15% MSM Drops, are recalled due to non-sterility, the U.S. Food and Drug Administration announced Friday. Using contaminated eye drops can result in the risk of eye infections that could result in blindness, the recall said.
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As of Saturday, there have been no reports of averse reactions to the use of Pharmedica’s Purely Soothing drops.
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The February drug resistant outbreak
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The recall comes on the heels of February alerts regarding eye drops from EzriCare and Delsam Pharma and reports of an outbreak of “extensively drug resistant” bacteria in Florida, New York, Texas, California and nine other states, according to the Centers for Disease Control and Prevention.
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That February outbreak strain, Pseudomonas aeruginosa, had never been reported in the United States before, the CDC said. Artificial tears was a common exposure for many patients and the EzriCare and Delsam Pharma drops were sold on the internet. As of March 1, 64 patients have been identified as infected in that outbreak. Of these, one has died and eight have reported vision loss.
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READ MORE: Death, blindness, eye drops recall: bacterial infections in Florida, Texas, other states
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READ MORE: More eye medicine recalled in 13-state outbreak of ‘drug-resistant’ bacteria infections
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The FDA notice did not say if this recall is related to the February eye drops alert.
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What to look for in Purely Soothing recall
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The Purely Soothing eye drop is used as an anti-inflammatory designed to help relieve ocular irritation and/or swelling.
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The drops are packaged in white, cylindrical high density polyethyline (HDPE) bottles.
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The Purely Soothing lots are:
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▪ LOT# 2203PS01, in 1 ounce size with UPC of 7 31034 91379 9.
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▪ LOT# 1808051, in half ounce size with UPC of 7 31034 91382 9.
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The bottles have eye dropper caps and white lids.
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What you should do
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If you have these lots of Purely Soothing eye drops Pharmedica USA says immediately stop using them and return them to the place of purchase. Wholesalers and retailers should stop distributing and return them to Pharmedica, too, “or confirm that the product has been disposed of with proper verification.”
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Questions?
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Consumers with questions about the Purely Soothing recall can call Pharmedica USA at 623-698-1752 between 8 a.m. and 5 p.m. Mountain Time, Monday-Friday, or e-mail osm@pharmedicausa.com.
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If you have any problems from using the recalled drops call your physician or healthcare provider.
