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Recall Observatory FDA recall evidence

Drug product

Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290.

D-903-2013

August 06, 2013

Class III

Product summary

Firm
Novartis Consumer Health
Event
Event 65840
Status
Terminated
Classification
Class III
Quantity
112,728 bottles
Official record key
drug-enforcement:D-903-2013

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 #: a) 10095538, Exp 07/13; 10099449, Exp 09/13; 10104663, Exp 01/14; 10111110, Exp 02/14; 10114312, Exp 04/14; 10120619, Exp 07/14; b) 10095537, Exp 07/13; 10099451, Exp 09/13; 10104664, Exp 01/14; 10111112, Exp 02/14; 10114313, Exp 04/14; 10120620, Exp 07/14; c) 10095528, Exp 07/13; 10106998, Exp 01/14; 10120618, Exp 07/14

Distribution pattern: Nationwide, Canada, and Panama.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect Or Missing