Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling
Novartis is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number and/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 and labeling issues (illegible dates) without reported injuries or illnesses.
Plain-English summary
Novartis Consumer Health is recalling Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor. The recall involves 3,451,224 bottles in 35-count, 65-count, and 90-count packages.
The reason for the recall is that 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 products were distributed nationwide, in Canada, and in Panama. Consumers should check their bottles for illegible lot or expiration dates and contact Novartis Consumer Health for further instructions or a refund.
The recalled product
- Product
- Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c)…
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Antacid
- Hazard
- Affected units
- 3,451,224
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) 10090971
- Exp 08/13
- 10101253
- Exp 09/13
- 10102751
- Exp 11/13
- 10104624
- Exp 01/14
- 10108954
- 10108955
- Exp 02/14
- 10111942
- 10111943
- Exp 03/14
- 10117575
- Exp 04/14
- b) 10095525
- Exp 07/13
- 10097329
- 10099437
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.
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