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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428.
Recall Number D-575-2013
Classification Class III
Code Info Lot number and exp date: 10104145 30-Apr-2013. (Vertical package) and Lot number and exp date: 10109587 30-Apr-2013, 10111508 31-May-2013; 10119095 31-Jul-2013 and 10119096 30-Sep-2013 (Horizontal package).
Product Distributed Qty 219,600 tubes
Reason For Recall The products have illegible lot and/or expiration dates on the product container.

Event Detail

Event Id 64372
Product Type Drugs
Status Ongoing
Recalling Firm Novartis Consumer Health
City Lincoln
State NE
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico, and Panama. Military distribution made.