Kadesh Inc. of Garden Grove, CA, is voluntarily recalling all lots of its Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, according to a notice posted on the U.S. Food and Drug Administration’s website.
During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, were “manufactured without necessary production controls and conditions to assure sterility,” according to the notice.
Use of a non-sterile eye drop is potentially vision-threatening due to the risk of an eye infection, FDA explains.
“Additionally, the pH of the product is relatively high and can cause direct destruction of tissues in the cornea, anterior chamber and deeper structures of the eye which can lead to scarring, glaucoma or vision loss,” according to the notice.
To date, Kadesh has not received any reports of adverse events related to the recall.
The product is an over-the-counter homeopathic eye drop for the temporary relief of burning and irritation due to dryness of the eye and discomfort due to minor irritations of the eye or to exposure to wind or sun. It is packaged in a 15 ml plastic bottle, NDC 7079600115, UPC 7 36972 1679 0.
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The product was distributed nationwide via the company’s own online stores and retail distributors.
