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

FDA recall notice · announced November 21, 2018 · Kadesh

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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

Reason for recall

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

Notes

Distribution: Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.
Lot/code information: All lots, no expiration dates are on the bottles.
Quantity: 18,521 bottles
Status: Terminated
Products in this recall event:
- puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0. (D-0250-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.