FDA Recall D-0250-2019
Kadesh International · Garden Grove, CA
Class I — life-threatening Terminated 1541 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0250-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.
- Recall initiated
- 2018-11-05
- Classified by FDA Center
- 2018-11-19
- FDA published
- 2018-11-21
- Terminated
- 2023-01-24
- Recalling firm
- Kadesh International
- Firm location
- Garden Grove, CA