Lubricant PM Ointment — Class II drug recall D-0354-2024
Ongoing recall by Brassica Pharma Pvt Ltd, reported 2024-03-06, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0354-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brassica Pharma Pvt Ltd, Thane, India |
| Recall initiated | 2024-01-30 |
| Classified | 2024-02-28 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 355,120 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00371406124356 |
| NDC | 71406-0124-35 |
| Lot numbers | A2G01, A2G02, A3F08, A3F09, A3J17, A3J18, JUN-24, MAY-25, SEP-25 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0354-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.