FDA Drug recall D-0354-2024
Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc…
- FDA Drug
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc… by Brassica Pharma Pvt, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0354-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-30 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Brassica Pharma Pvt |
| Distribution | US |
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
Lack of Assurance of Sterility
Identifiers
| upc | 371406124356 |
|---|---|
| code_info | Lot #: A2G01, A2G02, Exp. Date Jun-24; A3F08, A3F09, Exp. Date May-25; A3J17, A3J18, Exp. Date Sep-25 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0354-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.