Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

For Immediate Release

November 7, 2018

Contact

Consumers

Recall Department
contact@puriton.us

Announcement

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

Use of a non-sterile eye drop is potentially vision-threatening due to the risk of an eye infection. 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. To date, Kadesh, Inc. has not received any reports of adverse events related to this recall.

This 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. Kadesh, Inc. is voluntarily recalling all lots of Puriton Eye Relief Drops within expiry. The product was distributed nationwide via the company’s own online stores and retail distributors.

Kadesh, Inc. is notifying its distributors and customers by recall letter and is arranging for return of all recall products. Consumers and businesses that have the product, which is being recalled, are recommended to stop using and selling.

Consumers with questions regarding this recall can contact the Recall Department at contact@puriton.us, available Monday through Friday, from 9 am to 6 pm (Pacific Time). Product may be returned to Kadesh Inc., 4731 Lincoln Way, Garden Grove, CA 92841. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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