FDA recall D-0354-2024

Brassica Pharma Pvt Ltd · Class II · drug

Product

Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356

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-0354-2024