FDAClass IIIApril 2, 2014

SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% recall: Subpotent

SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton…

Why was SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% recalled?

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

13F016A exp. 12/14.

Product
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton…
Recalling firm
Hill Dermaceuticals, Inc.
Quantity
7,676 bottles
Distribution
Nationwide and Puerto Rico
Recall date
April 2, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls