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

Recall Number: D-0233-2022

Firm: Amneal Pharmaceuticals of New York, LLC

Classification: Class II

Status: Terminated

Report Date: 20211124

Initiation Date: 20211104

Termination Date: 20220609

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

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