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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
Recall Number D-1152-2014
Classification Class III
Code Info Lot #: 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15
Product Distributed Qty 493,192 tubes
Reason For Recall Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.

Event Detail

Event Id 67329
Product Type Drugs
Status Ongoing
Recalling Firm Fougera Pharmaceuticals Inc.
City Melville
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide.
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