Derma-smoothe/fs Oil
FDA Recall NDC 68791-101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Derma-smoothe/fs (NDC 68791-101). A significant event, classified as Class III, was initiated on Jan 31, 2014 by Royal Pharmaceuticals, Llc. The reported reason for this action was: "Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Jan 31, 2014
Apr 02, 2014
8,734 bottles
Recall Profile & Regulatory Data
Event ID
67420
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hill Dermaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 03, 2015
Product Description
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04
Batch or Lot Expiration Information
Lot# 13E013A exp. 11/14.
Affected Packages Involved in this Recall
68791-101-04Product
68791-101-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
