November 2018 FDA Recall Drug by Kadesh International
D-0250-2019 - Non-Sterility
This Class I drug recall was voluntarily initiated by Kadesh International on November 5, 2018 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0250-2019
Non-Sterility: Product manufactured under non-sterile production conditions.
11-05-2018
11-21-2018
18,521 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kadesh International
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.
01-24-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
Batch or Lot Expiration Information
Lot# All lots, no expiration dates are on the bottles.
