PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 31, 2017 Initiated: April 3, 2017 #D-0865-2017

Product Description

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.

Details

Recalling Firm
Cell Distributors
Units Affected
2,634 bottles (58 bottles/5mL & 2576 bottles/15 mL)
Distribution
Nationwide
Location
Union, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Cell Distributors. Units affected: 2,634 bottles (58 bottles/5mL & 2576 bottles/15 mL).
Why was this product recalled?
Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 31, 2017. Severity: Moderate. Recall number: D-0865-2017.