Mylanta, Alternagel Named in Latest Johnson & Johnson Drug Recall

Twelve Mylanta liquid products and one Alternagel liquid product are the latest Johnson & Johnson medications to be subject to a recall. The <"">Mylanta and Alternagel products, which are manufactured by Johnson & Johnson’s McNeil Consumer Healthcare unit, contain small amounts of alcohol not noted on the label.

Late last month, McNeil recalled around 9 million bottles of Tylenol Cold Multi-Symptom liquid products for a similar labeling issue. According to the recall notice, certain flavoring agents used in the medications contribute small (< 1%) amounts of alcohol. However, McNeil said that is unlikely that use of these products will cause either alcohol absorption or alcohol sensitivity related adverse events.

Like the Tylenol Cold Multi-Symptom liquid recall, the Mylanta and Alternagel recall is not being undertaken on the basis of adverse events. The company said no action is required by consumers or healthcare providers and consumers can continue to use the product. The recall is being issued at the retail and wholesale level only.

The recall affects as many as 12 million bottles of Mylanta and 85,000 bottles of Alternagel, according to a Reuters report. A complete list of the Mylanta and Alternagel products included in this recall, as well as their NDC numbers, Lot numbers, and UPC codes, is available here.

The Mylanta and Alternagel products involve in this recall were made at the company’s Lancaster, Pennsylvania.

This year, Johnson & Johnson has issued more than a half dozen recalls, including an April action that has the distinction of being the largest recall of children’s medicine in history. That recall involved 136 million bottles and 40 varieties of Tylenol, Motrin, Zyrtec and Benadryl.

Many of the recalled products were made at McNeil’s Fort Washington, Pennsylvania facility. That facility was temporarily closed earlier this year because of quality issues. The plant is expected to stay closed well into next year, and 75 percent of its workforce has been laid off.

Meanwhile, the US Food & Drug Administration (FDA) has again cited a McNeil manufacturing facility in Puerto Rico for a variety of manufacturing problems, according to a report in The New York Times. These include: distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff.

The new inspection report echoes problems found at the same plant that were cited in an FDA warning letter sent to McNeil’s president, Peter Luther, last January, the Times said. The Puerto Rico plant made millions of bottles of Tylenol, Motrin and other products that were recalled earlier this year. An FDA spokesperson told the newspaper that the new inspection report indicates that some problems have not been corrected.

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