Kadesh Recalls Puriton Eye Relief Drops for Non-Sterility
Kadesh International is recalling Puriton Eye Relief Drops because they were manufactured under non-sterile production conditions.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Kadesh International is recalling 18,521 bottles of Puriton Eye Relief Drops, 0.5 oz (15 ml) bottles. The recall is due to the product being manufactured under non-sterile production conditions.
The affected product is identified by NDC#7079600115 and UPC 7 36972 16799 0. All lots are affected, and no expiration dates are present on the bottles. The product was distributed via online stores and retail distributors nationwide in the USA, as well as in Uruguay, Canada, China, the Dominican Republic, Korea, and Vietnam.
Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
- Manufacturer
- Kadesh International
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 18,521
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All lots
- no expiration dates are on the bottles.
Distribution
Distributed nationwide across the United States.
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