Perrigo recalling 200M doses of antifungus drug over labeling mishap

Perrigo CEO Joseph Papa

Just weeks ago, Perrigo ($PRGO) CEO Joseph Papa had to tell consumers his company was recalling its store-brand knockoff of children's grape-flavored Mucinex because of the potential for dosing errors. Now, in yet another manufacturing stumble, the generics and over-the-counter specialist is recalling 200 million doses of a medication used to fight infections like diaper rash and thrush.

According to the most recent FDA Enforcement report, the Allegan, MI-based drugmaker is recalling two lots of the antifungal nystatin because of a labeling error on the declared strength. It initiated the recall Jan. 18, according to the notice. The report said the powder is used for compounding.

It was also in January that Perrigo started recalling its copy of children's grape-flavored Mucinex after learning that dosing cups may be mismarked, putting children at risk for being overdosed. While it said at the time that no adverse reactions had been reported, there was a risk of children taking too much of the med, which could lead to vomiting and other stomach problems.

The most recent retrieval is the third large recall for the drugmaker in less than 6 months. Last fall, it recalled 210,000 cartons of its generic of allergy pill Zyrtec that it also makes for retailers across the country. Perrigo initiated the recall of the antihistamine in late September after it found that the products potentially contained an impurity of cetirizine monosaccharide ester.

- see the recalls here and here

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