Why Were Maalox Tablets Recalled?


Quick Answer

Novartis recalled more than 4 million boxes of Maalox tablets in the summer of 2013, because expiration dates and lot numbers were not readable on the boxes' outer plastic wrapping, according to North Jersey Media Group. The Swiss pharmaceutical manufacturer voluntarily recalled nine varieties of its chewable tablets, including its Extra Strength and Advanced Maximum Strength Antacid and Antigas products. The recall included cherry, wild berry, mint and wintergreen flavors.

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Full Answer

Novartis recalled Maalox tablets that it produced before December 2011, at the company's consumer health manufacturing plant in Lincoln, Nebraska, according to FiercePharma. The recall covered improper package labeling as well as some bottles that may have been missing lot numbers or expiration dates. Novartis closed the Nebraska plant, corrected problems, retooled it, and reopened it as a streamlined operation that only produces powder and solid products. The company laid off 300 workers and expended $100 million for the restructuring, which involved moving some product lines from the Lincoln facility to a plant in Prangins, Switzerland.

Novartis had temporarily suspended production voluntarily at the Lincoln facility in December 2011, after a U.S. Food and Drug Administration inspection report concluded that the plant had serious problems, reports FiercePharma. The inspection report cited short staffing, lax maintenance, inadequate training and quality-control lapses that resulted in instances of placing drugs in the wrong containers.

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