FDAClass IINovember 24, 2021

Flocinolone Acetonide 0.01% Topical Oil recall: Subpotent

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

Why was Flocinolone Acetonide 0.01% Topical Oil recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 07030002A, exp. date 02/2022

Product
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
Recalling firm
Amneal Pharmaceuticals of New York, LLC
Quantity
15,88 bottles
Distribution
Product was distributed nationwide within the United States
Recall date
November 24, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls