Amneal Pharmaceuticals of New York, LLC recalls Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceutical…

Recall date

November 4, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0234-2022

FDA classification

Class II

Brand / firm

Amneal Pharmaceuticals of New York, LLC

Sold / distributed

Product was distributed nationwide within the United States

Why it was recalled

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.

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

What was recalled

Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86