FDAClass IIIAugust 28, 2013

Maalox Regular Strength Antacid recall: Labeling Error

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.

Why was Maalox Regular Strength Antacid recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
Novartis Consumer Health
Quantity
112,728 bottles
Distribution
Nationwide, Canada, and Panama.
Recall date
August 28, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls