D-0354-2024 Class II Ongoing

Recalled by Brassica Pharma Pvt Ltd — Thane

Recall Details

Product Type
Drugs
Report Date
March 6, 2024
Initiation Date
January 30, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
355,120 units

Product Description

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 Pattern

Nationwide within the United States

Code Information

Lot #: A2G01, A2G02, Exp. Date Jun-24; A3F08, A3F09, Exp. Date May-25; A3J17, A3J18, Exp. Date Sep-25