Recalls / Class III

Class IIID-008-2014

Product

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.

Affected lot / code info

K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14

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, Sanford, Florida 32773-9311

Distribution

Distribution pattern

Nationwide and Puerto Rico.

Timeline

Recall initiated

2013-09-08

FDA classified

2013-11-20

Posted by FDA

2013-11-27

Terminated

2014-08-04

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-008-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.