Lubricant PM Ointment recalled over sterility concerns
- Recall date
- January 30, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Brassica Pharma Pvt Ltd recalls Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE…
- Recall number
- D-0354-2024
- FDA classification
- Class II
- Brand / firm
- Brassica Pharma Pvt Ltd
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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