Pfizer recalls children's Advil in Canada; 'clumps' could cause dosing mistakes

Pfizer's Consumer Healthcare has recalled 126 lots of its children's Advil products in Canada because of a manufacturing issue that can throw off dosing. It is the second significant recall in recent weeks of a children's OTC med because of dosing concerns with last month's recall by Perrigo ($PRGO) of 5 lots of its grape-flavored knockoff of Mucinex for children.

Pfizer ($PFE) said in its announcement that "clumps" of the active ingredient ibuprofen may form in the bottle and that could lead to higher or lower doses that are given to infants and children if it is not shaken well before each use. While the company said the likelihood of serious reactions is remote, it warned that lower dosing could mean children wouldn't get enough of the med to reduce their fevers, in rare cases leading to convulsions. Too high a dose might result in vomiting, drowsiness, dizziness, "ringing in the ears" and decreased breathing rates.

The recall included 97 lots of Children's Advil, 20 lots of Advil Pediatric Drops, 4 lots of Children's Advil Fever from Colds or Flu, 3 lots of Children's Advil Cold, and 2 lots of Advil Pediatric Drops Fever from Colds or Flu.

"Our top priority is delivering safe and top quality products that Canadians can trust," David Lessard, director of quality and compliance for Pfizer Global Supply, said in a statement. "As soon as the product issue was identified, we took action to investigate any potential safety issues associated with the product."

The New York-based drugmaker said it discovered the problem during routine stability testing and tracked the problem to a change to an emulsifying ingredient (xanthan gum) from one of Pfizer's suppliers that allowed ibuprofen in the liquid suspension to separate over time. It said it has replaced the source of that ingredient.

In the case of the Perrigo recall of its store brand versions of Mucinex, the Allegan, MI-based Perrigo discovered that the dosing cups it got from a supplier may be mismarked, putting children at risk for being overdosed. In January, it began retrieving two batches of its children's guaifenesin grape liquid and three batches of its children's guaifenesin grape liquid DM.

It has been a number of years since the last significant recall of Advil by Pfizer. In 2012, it recalled 653,000 bottles of Advil gel tabs from stores because consumers had complained they had a strong odor.

- here's the Pfizer recall statement