FDA recall D-0919-2023

Product

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.

Distribution

Product was distributed to two distributors who further distributed Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2023-01-30

Report date

2023-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chennai, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0919-2023