The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-903-2013·Announced 2013-08-28

Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels

Novartis Consumer Health is recalling Maalox Regular Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle 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 labeling issues (illegible lot/expiration dates) without reported injuries or illnesses.

Plain-English summary

Novartis Consumer Health is recalling Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor. The recall involves 112,728 bottles in 50-count, 100-count, and 145-count packages. The product was distributed nationwide in the United States, as well as in Canada and 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 who have purchased these products should check their bottles for the affected lot numbers and expiration dates listed in the recall notice. If the product matches the recalled items, consumers should stop using it and contact Novartis Consumer Health for a refund or further instructions.

The recalled product

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.…
Manufacturer
Novartis Consumer Health
Category
Drug — Antacid
Hazard
Affected units
112,728

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 #: 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
  • 10099451
  • 10104664
  • 10111112
  • 10114313
  • 10120620
  • c) 10095528
  • 10106998

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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