FDA-Drug2021-11-24Class II
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
Amneal Pharmaceuticals of New York, LLC
Hazard
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Sold states
Product was distributed nationwide within the United States
Affected count
7,766 bottles
Manufactured in
50 Horseblock Rd, N/A, Brookhaven, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0233-2022Don't want to check this manually?
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