The Recall Desk
LowFDA (Drugs)·D-906-2013·Announced 2013-08-28

Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling

Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

What this means for you

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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is limited to illegible labeling.

Plain-English summary

Novartis Consumer Health is recalling Maalox Extra Strength Antacid (calcium carbonate) chewable tablets, 1000 mg, Wild Berry flavor. The recall involves 35-count and 65-count bottles manufactured by Novartis Consumer Health Canada Inc. The affected products are identified by specific lot numbers and expiration dates ranging from July 2013 to July 2014.

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 recall is classified as FDA Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The affected products were 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. If the product matches the recalled lots, consumers should stop using it and contact Novartis Consumer Health for further instructions or a refund.

The recalled product

Product
Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling c
Manufacturer
Novartis Consumer Health
Category
Drug — Antacid
Hazard
Affected units
149,616

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 (18)

  • Lot #: a) 10095535
  • Exp 07/13
  • 10101288
  • Exp 10/13
  • 10104665
  • Exp 01/14
  • 10111114
  • Exp 02/14
  • 10114314
  • Exp 04/14
  • 10120621
  • Exp 07/14
  • b) 10095536
  • 10101289
  • 10104666
  • 10111116
  • 10114315
  • 10120622

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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Same hazard · mis labeling

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