D-0250-2019 Class I Terminated
FDA drug recall D-0250-2019 was initiated by Kadesh International on November 5, 2018 and is designated Class I. Reason for recall: Non-Sterility: Product manufactured under non-sterile production conditions. The recall status is terminated (terminated January 24, 2023). Affected quantity: 18,521 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 21, 2018
- Initiation Date
- November 5, 2018
- Termination Date
- January 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,521 bottles
Product Description
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 Pattern
Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.
Code Information
All lots, no expiration dates are on the bottles.