Safety Alerts & Recalls

What does this mean?

This recall for the twelve Mylanta liquid products and the one AlternaGel liquid product was issued at a wholesale and retail level only. The FDA and the manufacturer have determined that any recalled product that may have been purchased by consumers does not pose a significant health risk. It is unlikely that use of these products will cause either alcohol absorption or alcohol sensitivity-related adverse events. Consumers with questions about this recall should call the Consumer Care Center at 1-800-469-5268 (available Monday-Friday from 8 a.m. - 8 p.m. ET and Saturday - Sunday, 9 a.m. - 5 p.m. Eastern Time.). If you think you are experiencing side effects from a Mylanta or AlternaGel liquid product and are concerned, please follow up with your doctor.

Johnson and Johnson Recalls Several Mylanta and AlternaGel Liquid Products

In consultation with the U.S. Food and Drug Administration (FDA), Johnson & Johnson-Merck Consumer Pharmaceuticals, Co. (JJMCP) is recalling twelve Mylanta liquid products and one AlternaGel liquid product. JJMCP initiated the recall after an internal review revealed that information about the presence of alcohol was not clearly displayed on the front product label. The presence of alcohol from flavoring agents was noted as an inactive ingredient listed on the package, but not on the front panel of the product. Certain flavoring agents contribute small (< 1%) amounts of alcohol. JJMCP is conducting the recall in order to update the labeling for these products.

The full recalled product list includes: Mylanta Regular Strength Original 12 FL OZ - NDC 16837-162-12

Mylanta Original 5 FL OZ - NDC 16837-162-55

Mylanta Regular Strength Mint 12 FL OZ - NDC 16837-138-12

Mylanta Maximum Strength Cherry 12 FL OZ - NDC 16837-136-12

Mylanta Maximum Strength Mint 12 FL OZ - NDC 16837-137-12

Mylanta Maximum Strength Original 12 FL OZ - NDC 16837-163-12

Mylanta Maximum Strength Original 24 FL OZ - NDC 16837-163-24

Mylanta Ultimate Strength Mint 12 FL OZ - NDC 16837-643-12

Mylanta Ultimate Strength Cherry 12 FL OZ - NDC 16837-644-12

Mylanta Supreme Tasting with Calcium Cherry 12 FL OZ - NDC 16837-825-12

Mylanta Supreme Tasting with Calcium Cherry 24 FL OZ - NDC 16837-825-24

Mylanta Maximum Strength Original 12 FL OZ - NDC 16837-163-12

Alternagel 12 FL OZ - NDC 16837-860-12

The affected product name and NDC numbers can be found on the product's front panel.

This recall is at the wholesale and retail level. There is no indication that the recalled products do not meet quality standards, and this recall is not being undertaken on the basis of adverse events. No action is required by consumers or healthcare providers and consumers can continue to use the product.

For more information and a full list of recalled lot numbers, please visit: more information here

Source: FDA
Publication Date: 2010-12-02
Last Updated: 2010-12-02
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