The Recall Desk
LowFDA (Drugs)·D-904-2013·Announced 2013-08-28

Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels

Novartis Consumer Health is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle.

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 by definition is unlikely to cause adverse health consequences. The hazard is limited to packaging labeling issues (illegible lot/expiration dates) without reported injuries or illnesses.

Plain-English summary

Novartis Consumer Health is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count bottles. The recall involves 410,220 bottles distributed nationwide, in Canada, and in Panama.

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.

Consumers with this product should check the lot number and expiration date on the bottle. If the information is illegible or matches the affected lots listed in the recall, consumers should stop using the product and contact Novartis Consumer Health for instructions on disposal or return.

The recalled product

Product
Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-6
Affected units
410,220

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 (20)

  • Lot #: 10093113
  • Exp 06/13
  • 10097332
  • Exp 08/13
  • 10101258
  • Exp 10/13
  • 10104632
  • Exp 12/13
  • 10108852
  • Exp 01/14
  • 10104633
  • 10110688
  • Exp 02/14
  • 10111944
  • Exp 03/14
  • 10114325
  • Exp 05/14
  • 10120609
  • 10120610
  • 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 →