Use of faulty products could expose consumers to the risk of eye infections that could lead to blindness.
The maker of Purely Soothing eye drops is recalling two lots of the product because they were not sterilized.
As of last week, Phoenix-based Pharmedica USA LLC said it had not received any reports of adverse events or illness related to the recalled product, which is 15% methylsulfonyl methane (MSM).
The product was distributed worldwide. Users of the affected products risk infection and potentially blindness.
The eye drop is used as an anti-inflammatory designed to assist with symptoms of eye irritation and/or swelling and is packaged in white, cylindrical bottles. The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids.
The announcements follow a recall last month of eye drops made in India that were linked to an outbreak of drug-resistant infections. One person died and at least five others had permanent vision loss.
Last week, the FDA posted a separate recall announcement from Apotex recalling six lots of prescription eye drops used to treat a form of glaucoma. The company said it launched the recall after finding cracks in some bottle caps.
There’s no indication the latest recalls are related to those products.
Pharmedica is advising customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing and return to Pharmedica USA LLC immediately or confirm that the product has been disposed of, with proper verification.
Consumers with questions regarding this recall can contact Pharmedica USA by phone at +1-623-698-1752 or by email at [email protected].