The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-902-2013·Announced 2013-08-28

Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling

Novartis is recalling Maalox Extra Strength Antacid with Anti-Gas chewable tablets because the lot number and expiration date may be illegible on the packaging.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is limited to packaging and labeling issues.

Plain-English summary

Novartis Consumer Health is recalling 117,816 bottles of Maalox Extra Strength Antacid with Anti-Gas chewable tablets. The product is a 65-count bottle containing calcium carbonate and simethicone in Assorted Fruit flavor.

The recall was initiated because the lot number and/or expiration date may be illegible on the outer plastic bottle packaging. This labeling issue prevents consumers from verifying the specific lot and expiration date of the product.

The affected product was distributed nationwide in the United States, as well as in Canada and Panama. Consumers should check their bottles for the specific lot numbers and expiration dates listed in the recall notice and stop using the product if it matches the recalled lots.

The recalled product

Product
Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN…
Manufacturer
Novartis Consumer Health
Category
Drug — Antacid
Hazard
Affected units
117,816

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot #: 10097345
  • Exp 08/13
  • 10104668
  • Exp 01/14
  • 10114317
  • Exp 03/14
  • 10120624
  • Exp 07/14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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