Fluocinolone Acetonide
FDA Recall NDC 0713-0222
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Fluocinolone Acetonide (NDC 0713-0222). A significant event, classified as Class III, was initiated on Sep 30, 2013 by Cosette Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Content Uniformity Specifications; at the 18 month time point."
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
September 2013 Class III Recall: Failed Content Uniformity Specifications; at the 18 month time point.
Recall Number
Class III Terminated
Failed Content Uniformity Specifications; at the 18 month time point.
Sep 30, 2013
Jan 08, 2014
187,368 metal tubes
Recall Profile & Regulatory Data
Event ID
66454
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
G & W Laboratories Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 28, 2014
Product Description
G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
Batch or Lot Expiration Information
Lot# 15 gm
Lot# : 022211002, 022212001- 022212008, 022212010-022212012, 022212017, 022213001, 022213005, 022213008 60 gm
Lot# : 022211002, 022212001- 022212007, 022212009, 022212010, 022212012-022212016, 022212018, 022212019, 022213002.
Affected Packages Involved in this Recall
0713-0222-15Product
0713-0222-60Product
0713-0223-15Product
0713-0223-60Product
0713-0224-15Product
0713-0224-60Product
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.
