FDA recall D-0407-2025

Product

Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.

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-0407-2025