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.