Home / Recalls / Amneal Pharmaceuticals of New York, LLC / D-0233-2022

D-0233-2022 Class II Terminated

Recalled by Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY

Recall Details

Product Type
Drugs
Report Date
November 24, 2021
Initiation Date
November 4, 2021
Termination Date
June 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,766 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

Product was distributed nationwide within the United States

Code Information

Lot #: 07040001A, exp. date 02/2022

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