September 2013 FDA Recall Fluocinolone Acetonide by G & W Laboratories Inc
D-391-2014 - Failed Content Uniformity Specifications; at the 18 month time point.

This Class III drug recall was voluntarily initiated by G & W Laboratories Inc on September 30, 2013 for the product Fluocinolone Acetonide. The FDA reported the reason for recall as failed content uniformity specifications; at the 18 month time point.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-391-2014

Reason for Recall
Failed Content Uniformity Specifications; at the 18 month time point.
Initiated
09-30-2013
Reported
01-08-2014
Quantity
187,368 metal tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66454
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
G & W Laboratories Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2014
Product Description About Product Description
Full technical description of the product.
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

0713-0222-15 Fluocinolone Acetonide
0713-0222-60 Fluocinolone Acetonide
0713-0223-15 Fluocinolone Acetonide
0713-0223-60 Fluocinolone Acetonide
0713-0224-15 Fluocinolone Acetonide
0713-0224-60 Fluocinolone Acetonide