FDAClass INovember 21, 2018

puriton EYE RELIEF DROPS recall: Sterility Concern

puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.

Why was puriton EYE RELIEF DROPS recalled?

Non-Sterility: Product manufactured under non-sterile production conditions.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots, no expiration dates are on the bottles.

Product
puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
Recalling firm
Kadesh International
Quantity
18,521 bottles
Distribution
Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.
Recall date
November 21, 2018
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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