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FDANovember 4, 2021drug

Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

amneal pharmaceuticalsamneal

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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