FDA recall D-0233-2022

Amneal Pharmaceuticals of New York, LLC · Class II · drug

Product

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

Product was distributed nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2021-11-04
Report date: 2021-11-24
Termination date: 2022-06-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0233-2022