PlainRecalls
FDA Drug Moderate Class II Ongoing

Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.

Reported: May 14, 2025 Initiated: April 23, 2025 #D-0405-2025

Product Description

Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.

Reason for Recall

cGMP deviations and lack of assurance of sterility.

Details

Units Affected
1,610 cases (24 cartons per case)
Distribution
Nationwide in the USA
Location
Saint Louis, MO

Frequently Asked Questions

What product was recalled?
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.. Recalled by BRS Analytical Services, LLC. Units affected: 1,610 cases (24 cartons per case).
Why was this product recalled?
cGMP deviations and lack of assurance of sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 14, 2025. Severity: Moderate. Recall number: D-0405-2025.