CLASS II ONGOING Drug recall · Reported 6 Mar 2024 · FDA Enforcement Report
Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%) recalled
Brassica Pharma is recalling Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), distributed nationwide in the US. The recall was initiated on 30 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0354-2024
- FDA event ID
- 93885
- Recalling firm
- Brassica Pharma, Thane
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jan 2024
- FDA classified
- 28 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 30 Jan 2024 | Recall initiated by company | |
| 28 Feb 2024 | Classified by FDA | +29 days |
| 6 Mar 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: A2G01, A2G02, Exp. Date Jun-24; A3F08, A3F09, Exp. Date May-25; A3J17, A3J18, Exp. Date Sep-25
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 93885This product is part of a recall event; the main page for the event is Equate Lubricant Eye Ointment (Mineral Oil recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Equate Lubricant Eye Ointment (Mineral Oil recalled | Brassica Pharma | Sterility | Nationwide | |
| CLASS II | CVS Health Lubricant Eye Ointment recalled by Brassica Pharma Pvt | Brassica Pharma | Sterility | Nationwide | |
| CLASS II | Equate Stye Lubricant Eye Ointment (Mineral Oil recalled | Brassica Pharma | Sterility | Nationwide |
More recalls from Brassica Pharma
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Equate Stye Lubricant Eye Ointment (Mineral Oil recalled | Brassica Pharma | Sterility | Nationwide |
| Drug | CLASS II | CVS Health Lubricant Eye Ointment recalled by Brassica Pharma Pvt | Brassica Pharma | Sterility | Nationwide |
| Drug | CLASS II | Equate Lubricant Eye Ointment (Mineral Oil recalled | Brassica Pharma | Sterility | Nationwide |