FDA recall D-0405-2025

BRS Analytical Services, LLC · Class II · drug

Product

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.

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-04-23
Report date: 2025-05-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0405-2025