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U.S. Department of Health and Human Services

Enforcement Report - Week of January 8, 2014

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Product Detail

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
Recall Number D-391-2014
Classification Class III
Code Info 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.
Product Distributed Qty 187,368 metal tubes
Reason For Recall Failed Content Uniformity Specifications; at the 18 month time point.

Event Detail

Event Id 66454
Product Type Drugs
Status Ongoing
Recalling Firm G & W Laboratories Inc
City South Plainfield
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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