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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 Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44840 4.
Recall Number D-908-2013
Classification Class III
Code Info Lot #: 10093133, Exp 06/13; 10099452, Exp 09/13; 10104667, Exp 12/13; 10110926, Exp 02/14; 10114316, Exp 04/14; 10120623, Exp 07/14; 10123098, Exp 09/14
Product Distributed Qty 129,048 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.