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

FDA recall notice · announced November 24, 2021 · Amneal Pharmaceuticals Of New York

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

Reason for recall

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

Notes

Distribution: Product was distributed nationwide within the United States
Lot/code information: Lot #: 07040001A, exp. date 02/2022
Quantity: 7,766 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0234-2022)
- 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 (D-0233-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.