SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil recall: Subpotent
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals…
Why was SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil 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?
13F017B exp. 12/14, 13F020B exp 12/14
- Product
- SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals…
- Recalling firm
- Hill Dermaceuticals, Inc.
- Quantity
- 13,591 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- April 2, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)