[11/8/2018] The Food and Drug Administration is alerting consumers about a voluntary recall of all lots of Puriton Eye Relief Drops, 0.5 oz. (15 ml) bottle. These products are labeled as a homeopathic and are being recalled due to non-sterile production conditions at the manufacturing facility. Consumers should stop using this product and contact their physician or Health care provider if they experience any problems that may be related to using this product.

Puriton Eye Relief Drops are over-the-counter homeopathic eye drops marketed for the temporary relief of burning and irritation due to eye dryness and eye discomfort due to minor irritations or to exposure to wind or sun. Kadesh, Inc., is voluntarily recalling all non-expired lots of Puriton Eye Relief Drops. The company distributed the product nationwide via its own online stores and retailers.

Use of a non-sterile eye drop product is potentially vision-threatening due to the risk of an eye infection. Additionally, the pH of this 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.

FDA is not aware of any adverse event reports associated with Puriton Eye Relief Drops. Health care professionals and patients should report any adverse events to the MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.