FDA recall D-0307-2024

Kilitch Healthcare India Limited · Class I · drug

Product

Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3

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-0307-2024