The Recall Desk
LowFDA (Drugs)·D-909-2013·Announced 2013-08-28

Novartis Recalls Maalox Nighttime Antacid Due to Illegible Packaging Labels

Novartis Consumer Health is recalling Maalox Nighttime 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 by definition is unlikely to cause adverse health consequences. The hazard is limited to packaging legibility issues.

Plain-English summary

Novartis Consumer Health is recalling 23,856 bottles of Maalox Nighttime Antacid with Acid Reflux Barrier chewable tablets. The product is a 65-count bottle containing calcium carbonate and alginic acid in Mint flavor. The recall was initiated because the lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

The affected products are identified by Lot # 10107000 (Exp 07/13) and Lot # 10114319 (Exp 01/14). The product was distributed nationwide in the United States, as well as in Canada and Panama. The manufacturer is Novartis Consumer Health Canada Inc., located in Mississauga, ON.

Consumers with this product should check the packaging for the specific lot numbers and expiration dates listed above. If the lot number or expiration date is illegible, consumers should stop using the product and contact Novartis Consumer Health for further instructions.

The recalled product

Product
Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80
Affected units
23,856

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 (4)

  • Lot #: 10107000
  • Exp 07/13
  • 10114319
  • Exp 01/14

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 →