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Recall Observatory FDA recall evidence

Drug product

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.

D-908-2013

August 06, 2013

Class III

Product summary

Firm
Novartis Consumer Health
Event
Event 65840
Status
Terminated
Classification
Class III
Quantity
129,048 bottles
Official record key
drug-enforcement:D-908-2013

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 #: 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

Distribution pattern: Nationwide, Canada, and Panama.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect Or Missing