FDA recalls Lubricant PM Ointment due to sterility assurance failure
Lubricant PM Ointment is being recalled by AACE Pharmaceuticals due to the manufacturer's failure to assure the product was manufactured under sterile conditions.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Lack of sterility assurance on a topical product represents a risk-of-harm product that could pose significant contamination and infection risk if applied to skin. This meets the rubric criterion for High severity.
Plain-English summary
Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), packaged in 3.5-gram tubes, is being recalled because the manufacturer failed to assure that the product was manufactured under sterile conditions. Lack of proper sterility assurance in a topical ointment poses a potential risk of contamination.
The product was distributed nationwide. Approximately 355,120 units are involved in this recall, distributed by AACE Pharmaceuticals, Inc. (Fairfield, NJ 07004). The affected lot numbers are A2G01 and A2G02 (expiring June 2024), A3F08 and A3F09 (expiring May 2025), and A3J17 and A3J18 (expiring September 2025). The product identification is NDC 71406-124-35 and UPC 371406124356.
Consumers and healthcare providers should stop use and return the product to the distributor for appropriate disposal.
The recalled product
- 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
- Manufacturer
- Brassica Pharma Pvt Ltd
- Category
- Drug — Topical Ointment
- Hazard
- Affected units
- 355,120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot #: A2G01
- A2G02
- Exp. Date Jun-24
- A3F08
- A3F09
- Exp. Date May-25
- A3J17
- A3J18
- Exp. Date Sep-25
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Brassica Pharma Pvt Ltd under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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