Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals
Summary
The FDA issued a Class II for Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, by Amneal Pharmaceuticals of New York, LLC. Reason: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide..
Details
Source
Drug Recall
External ID
D-0233-2022
Action Date
2021-11-24
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: 07040001A, exp. date 02/2022
Quantity Affected: 7,766 bottles
Reason for Recall
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Distribution
Product was distributed nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-04
Company
Brookhaven, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 178 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amneal Pharmaceuticals of New York, LLC has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amneal Pharmaceuticals of New York, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amneal Pharmaceuticals of New York, LLC have FDA actions?
Amneal Pharmaceuticals of New York, LLC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0233-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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