Recalls / Class III
Class IIID-1178-2014
Product
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
- Brand name
- Dermotic
- Generic name
- Fluocinolone Acetonide
- Active ingredient
- Fluocinolone Acetonide
- Route
- Auricular (otic)
- NDC
- 68791-103
- FDA application
- NDA019452
- Affected lot / code info
- 13F015B exp. 12/14, 13G023B exp. 01/15
Why it was recalled
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recalling firm
- Firm
- Hill Dermaceuticals, Inc.
- Manufacturer
- Royal Pharmaceuticals
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 2650 S Mellonville Ave, N/A, Sanford, Florida 32773-9311
Distribution
- Quantity
- 13,379 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-01-31
- FDA classified
- 2014-03-24
- Posted by FDA
- 2014-04-02
- Terminated
- 2015-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1178-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.