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Class II · ModerateRecall completed

Flocinolone Acetonide 0.01% Topical Oil

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 07040001A, exp. date 02/2022
Where it was soldProduct was distributed nationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forAmneal Pharmaceuticals Bridgewater, NJ 08807
NDC65162-704-86
Show the full FDA record
Full product labelFlocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
Recalling firmAmneal Pharmaceuticals of New York, LLC
DistributionProduct was distributed nationwide within the United States
Quantity7,766 bottles
Recall initiated2021-11-04
Report date2021-11-24
Recall completed2022-06-09
Recall numberD-0233-2022
ClassificationClass II
FDA statusTerminated
Origin on fileBrookhaven NY United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.