FDA recall D-0353-2024

Brassica Pharma Pvt Ltd · Class II · drug

Product

CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141

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-0353-2024