ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone recall: Subpotent
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal…
Why was ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone 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?
13E014A exp. 11/14, 13F02C exp 12/14.
- Product
- ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal…
- Recalling firm
- Hill Dermaceuticals, Inc.
- Quantity
- 7,292 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- April 2, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)