Recalls / Class III
Class IIID-1181-2014
Product
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20
- Affected lot / code info
- 13F017B exp. 12/14, 13F020B exp 12/14
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.
- 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
- 13,591 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-1181-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.