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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-65 9.
Recall Number D-904-2013
Classification Class III
Code Info Lot #: 10093113, Exp 06/13; 10097332, Exp 08/13; 10101258, Exp 10/13; 10104632, Exp 12/13; 10108852, Exp 01/14; 10104633, 10110688, Exp 02/14; 10111944, Exp 03/14; 10114325, Exp 05/14; 10120609, 10120610, Exp 07/14; 10123084, Exp 09/14
Product Distributed Qty 410,220 bottles
Reason For Recall Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Event Detail

Event Id 65840
Product Type Drugs
Status Ongoing
Recalling Firm Novartis Consumer Health
City Lincoln
State NE
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Canada, and Panama.
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