Recall: Puriton Eye Relief Drops, 0.5 Oz. (15ml) Bottle
On 2018-11-07, the FDA announced that Kadesh is conducting a recall on Eye Relief Drops, 0.5 Oz. (15ml) Bottle due to a possible lack of sterility. The recalled products were sold under the brand name(s) Puriton during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 2 drugs recalls due to potential lack of sterility, including sterile compounded drugs, compounded drug products and more. Additionally, there have been 24 drug and medical device recalls due to other health hazards as well as 80 food recalls.
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Eye Relief Drops, 0.5 oz. (15ml) bottle
Brand Name(s): Puriton
Reason for Recall: Lack of Sterility
Official Recall Date: 2018-11-07
Additional information provided by the FDA.gov:
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. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.