FDA-Drug2024-03-06Class II
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
Brassica Pharma Pvt Ltd
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
355,120 units
Manufactured in
Plot No. T-68, T 68 (Pt), T-63, Midc, Tarapur, Boisar, Thane, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0354-2024Don't want to check this manually?
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