Drug product
puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
D-0250-2019
Product summary
- Event
- Event 81512
- Status
- Terminated
- Classification
- Class I
- Quantity
- 18,521 bottles
- Official record key
drug-enforcement:D-0250-2019
Official wording
Reason: Non-Sterility: Product manufactured under non-sterile production conditions.
Code information: All lots, no expiration dates are on the bottles.
Distribution pattern: Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.
Derived failure modes
-
Unknown
Non-Sterility: Product manufactured under non-sterile production conditions.