FDA recall D-0303-2024

Kilitch Healthcare India Limited · Class I · drug

Product

EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01

Reason for recall

Non-Sterility

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2023-11-13
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Navi Mumbai, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0303-2024