Parents needing to treat their children during this cold season are facing another hurdle after Pfizer ($PFE) pulled 126 lots of children's and infants' Advil products from retailer shelves in Canada over dosing concerns. The recall of that children's med comes just weeks after Perrigo ($PRGO) yanked all its store brands of its grape-flavored Mucinex knockoff from retailers in the U.S.
Drugmakers hold back product that they periodically test to see how it is holding through its expiry dates. Pfizer Consumer Healthcare said that during that routine testing, it discovered "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.
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.
Pfizer in its notice said the likelihood of serious reactions is remote but it warned that lower dosing could mean children wouldn't get enough of the med to reduce their fevers. In rare cases, that could lead to convulsions. Too high a dose might result in vomiting, drowsiness, dizziness, 'ringing in the ears' and decreased breathing rates.
"Our top priority is delivering safe and top quality products that Canadians can trust," David Lessard, director of quality & 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." Pfizer said it has tracked the cause of the problem and that it has been resolved.
Last month it was OTC specialist, Allegan, MI-based Perrigo that had to pull children's meds from the market. In that case, it was Perrigo's store brands of the popular mucus thinner Mucinex. Perrigo said it had discovered that the dosing cups it got from a supplier may have been 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.
- here's the Pfizer recall statement