Drug & medication recalls Moderate risk

Lexette Topical Foam recalled over manufacturing violations

Recall date
January 14, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Mayne Pharma Inc recalls Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville,…
Recall number
D-0387-2022
FDA classification
Class II
Brand / firm
Mayne Pharma Inc
Sold / distributed
Nationwide within the United States

Why it was recalled

CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50

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