FDAFDA · Food and drugs·Recall number D-0234-2022
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
Published November 24, 2021 · Recall initiated: November 4, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- Product was distributed nationwide within the United States
- Lot
- Lot #: 07030002A, exp. date 02/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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