FDA recall D-0408-2025

BRS Analytical Services, LLC · Class II · drug

Product

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.

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-0408-2025