FDA recall D-0352-2024

Brassica Pharma Pvt Ltd · Class II · drug

Product

Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304

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-0352-2024