Drug recall D-0234-2022

Class II Terminated reported Nov 24, 2021

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY
Quantity
15,88 bottles
Distribution
Product was distributed nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
November 4, 2021
Terminated
June 9, 2022

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