ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone recall: Subpotent
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal…
Why was ROYAL PHARMACEUTICALS DermOtic Oil 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?
13F015B exp. 12/14, 13G023B exp. 01/15
- Product
- ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal…
- Recalling firm
- Hill Dermaceuticals, Inc.
- Quantity
- 13,379 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- April 2, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)