Alka-Seltzer Plus Labeling Error Prompts Recall From Some US Stores
Recall is second in a year for products marketed under the iconic Alka-Seltzer brand.
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In response to the US agency's guidance announced Nov. 6, the pharmaceutical firm whose name is synonymous with the ingredient aspirin, Bayer, says it is considering how it will change labeling now used for most Bayer Aspirin products that includes a statement similar to the recommended language.
“There is a ton of work still for us to do,” Erica Mann, Bayer’s global consumer head, said after the firm reported disappointing second-quarter results. The root of the problem is over-estimating the revenue boost from former Merck & Co. brands, the firm says.
Comments from the Nonprescription Drug and the Drug Safety and Risk Management advisory committees during a joint meeting could push US FDA toward pulling the plug on hangover as a monograph indication.