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
Reported: November 24, 2021 Initiated: November 4, 2021 #D-0234-2022
Product Description
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
Reason for Recall
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Details
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC
- Units Affected
- 15,88 bottles
- Distribution
- Product was distributed nationwide within the United States
- Location
- Brookhaven, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amneal Pharmaceuticals of New York, LLC. Units affected: 15,88 bottles.
Why was this product recalled? ▼
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 24, 2021. Severity: Moderate. Recall number: D-0234-2022.
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