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Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: ...

FDA Recall #D-0233-2022 — Class II — November 4, 2021

Recall #D-0233-2022 Date: November 4, 2021 Classification: Class II Status: Terminated

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.

Recalling Firm

Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

7,766 bottles

Distribution

Product was distributed nationwide within the United States

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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