FDA recall D-0351-2024

Brassica Pharma Pvt Ltd · Class II · drug

Product

Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2024-01-30
Report date
2024-03-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Thane, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0351-2024