Recall Enforment Report D-0233-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Amneal Pharmaceuticals of New York, LLC, originally initiated on 11-04-2021 for the 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 The product was recalled due to subpotent drug: out-of-specification assay result was obtained for fluocinolone acetonide.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0233-202211-04-202111-24-2021Class II7,766 bottlesFlocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.Ongoing
D-0234-202211-04-202111-24-2021Class II15,88 bottlesFlocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
65162-703Fluocinolone Acetonide Fluocinolone AcetonideOilTopicalAmneal Pharmaceuticals LlcHuman Prescription Drug
65162-704Fluocinolone Acetonide Fluocinolone AcetonideOilTopicalAmneal Pharmaceuticals LlcHuman Prescription Drug