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
D-0354-2024
Product summary
- Event
- Event 93885
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 355,120 units
- Official record key
drug-enforcement:D-0354-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: A2G01, A2G02, Exp. Date Jun-24; A3F08, A3F09, Exp. Date May-25; A3J17, A3J18, Exp. Date Sep-25
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility