Class IIReported 2025-05-14

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

Reason for Recall

cGMP deviations and lack of assurance of sterility.

Recall Number

D-0405-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-04-23

Reported

2025-05-14

Distribution

Nationwide in the USA

Code Info

Lot, expiry: Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.