Puriton EYE RELIEF DROPS recalled over sterility concerns

Recall date

November 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Kadesh International recalls puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.

Recall number

D-0250-2019

FDA classification

Class I

Brand / firm

Kadesh International

Sold / distributed

Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.

Why it was recalled

Non-Sterility: Product manufactured under non-sterile production conditions.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.