FDA recall D-0250-2019

Kadesh International · Class I · drug

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-11-05
Report date
2018-11-21
Termination date
2023-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Garden Grove, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0250-2019