Drug & medication recalls Moderate risk

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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