PlainRecalls
FDA Drug Critical Class I Ongoing

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.

Reported: July 19, 2023 Initiated: January 30, 2023 #D-0919-2023

Product Description

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.

Reason for Recall

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Details

Units Affected
400,008 bottles total for all products
Distribution
Product was distributed to two distributors who further distributed Nationwide in the USA.
Location
Chennai, N/A

Frequently Asked Questions

What product was recalled?
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.. Recalled by Global Pharma Healthcare Private Limited. Units affected: 400,008 bottles total for all products.
Why was this product recalled?
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 19, 2023. Severity: Critical. Recall number: D-0919-2023.