Over-the-counter specialist Perrigo said on Monday that it was recalling some of its children's grape-flavored Mucinex copies after learning that dosing cups may be mismarked, putting children at risk for being overdosed. It said for some children, taking too much of the med could lead to vomiting and other stomach problems.
The Allegan, MI-based drugmaker said no adverse events have been reported so far, but it is recalling two batches of its children's guaifenesin grape liquid and three batches of its children's guaifenesin grape liquid DM because of the potential problem with the dosing cups.Perrigo CEO Joseph Papa
"Perrigo is taking this action to maintain the highest possible product quality standards for our retail customers and consumers," CEO Joseph Papa said in a statement. "We are taking this action because it is the right thing to do."
The generic Mucinex recall comes even as Perrigo ($PRGO) is recalling nearly 210,000 cartons of its generic of allergy pill Zyrtec that it also makes for retailers across the country. Unfortunately for consumers, the recall comes just months after Novartis ($NVS) had to yank about 1 million units of its copy of the top-selling antihistamine.
According to the most recent FDA Enforcement Report, Perrigo is recalling 209,256 cartons of blister packs of cetirizine HCl 10-mg tablets that are sold under their own store brand names by CVS, Kmart, Kroger, HEB, and Safeway. While it is just now showing up in the FDA Enforcement Report, Perrigo initiated the recall of the antihistamine in late September after it found that the products potentially contained an impurity of cetirizine monosaccharide ester.
A suspected impurity was also behind the recall by Novartis' generics business last spring. In April, Sandoz recalled 1,023,430 blister packs of cetirizine HCl chewable tablets. It said the 9 lots were recalled after they were found to be out of specification for impurities when tested at 21 months. The recall says those products were made at a Sandoz plant in Mumbai. Sandoz has since said it intends to close the Mumbai plant this year.
The Perrigo recalls come at a very inopportune time for the company. In November, Papa convinced shareholders the company was better off on its own than accepting a $26 billion takeover offer from Mylan ($MYL). To help convince shareholders, the company initiated a $2 billion share buyback program and pledged to cut costs, in part by eliminating about 800 jobs. The company has said that part of those cuts will come by tightening up its supply chain operations, although it has not provided specifics on how that will be done.
- here's the cold med recall notice
- here's the Perrigo antihistamine recall notice