FDA recall D-0865-2017

Product

Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ

Reason for recall

Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-04-03

Report date

2017-05-31

Termination date

2019-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Union, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0865-2017