The recall was due to non-sterile conditions during production.
When the FDA inspected the production site, the investigators discovered that the necessary production controls and conditions for sterility were not being observed.
Opthalmic drugs are required to be sterile in particular, because using a non-sterile eye drop can potentially threaten the vision of the consumer due to the risk of an eye infection. Also, the pH factor of the eye drops can cause direct destruction of tissues in the anterior chamber, cornea, and even deeper in the eye.
This can potentially cause scarring, vision loss, or glaucoma.
To date, there have been no reports of adverse effects related to the Puriton Eye Relief Drops.
Purtion Eye Relief Drops is an over-the-counter homeopathic eye drop product. Its uses include temporary relief of burning and irritation of the eye due to dryness and temporary relied of discomfort due to minor irritations to the eye, like wind and sun exposure. Other uses were the relief of redness, watery eyes, inflamed eyes, itching, burning, tearing eyes, eye pain, and lubricant.
Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton EyeRelief Drops , 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level.
It is packaged in a 15 ml plastic bottle, and was distributed nationwide through the company’s online stores and the retail distributors they work with. All distributors and customers are being notified by letter and Kadesh is arranging for the return of all the recalled products.
As of now, the product cannot be found anywhere online, neither on the Puriton website nor online markets like Amazon.
Anyone who has recalled eye drops should stop usage or sale of the product.
Consumers with questions regarding this recall can contact the Recall Department at firstname.lastname@example.org, available Monday through Friday, from 9 am to 6 pm (Pacific Time).
Product may be returned to Kadesh Inc. by mail:
4731 Lincoln Way, Garden Grove, CA 92841.
Anyone who experienced any problems that may be related to the use of the non-sterile product should contact their healthcare provider.
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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