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Recall Observatory FDA recall evidence

Drug product

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.

D-904-2013

August 06, 2013

Class III

Product summary

Firm
Novartis Consumer Health
Event
Event 65840
Status
Terminated
Classification
Class III
Quantity
410,220 bottles
Official record key
drug-enforcement:D-904-2013

Official wording

Reason: 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.

Code information: 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

Distribution pattern: Nationwide, Canada, and Panama.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect Or Missing