Children’s Advil Recall Issued In Canada Over Dosing Concerns

Amid concerns about a potential risk of overdoses, Children’s Advil bottles distributed in Canada are being recalled after it was discovered clumps of ibuprofen may form as the medicine reaches it’s expiration date if not shaken before administering doses.

The children’s and infants Advil recall was announced by Health Canada on February 12, impacting tens of thousands of bottles manufactured and sold by Pfizer.

While no injuries have been reported from under or overdosing, the manufacturer indicates that clumps of the active ingredient, ibuprofen, may occur in the recalled Advil if the bottles are not shaken properly. The risk of problems with the liquid Cold and Pediatric Advil medicines were discovered during routine testing

Ibuprofen is an anti-inflammatory drug as the active ingredient in many over the counter pain relief medications. Pfizer concluded from their testing that an emulsifying ingredient, xanthan gum, can cause the ibuprofen in the liquid suspension to separate over time, resulting in the clumping issue.

Over and under dosing children with Advil can lead to serious adverse health consequences. Children that receive lower dosages than intended would not receive enough to reduce fevers and in severe situations could result in convulsions, whereas an overdose from the ibuprofen clumping could lead to vomiting, drowsiness, dizziness, decreased breathing rates and ringing of the ears.

Pfizer Global Supply’s Director of Quality and Compliance, David Lessard, announced in the recall notice that the likelihood of serious reactions are remote, but as soon as the issue was discovered the company took action to investigate and track the source of the clumping problem, which has since been resolved.

The recall includes a total of 126 lots of children’s and infants liquid form Advil. According to the recall notice, the breakdown of recalled products includes 97 lots of Children’s Advil, 20 lots of Advil Pediatric Drops, 4 lots of Children’s Advil Fever from Cold or Flu, 3 lots of Children’s Advil Cold, and 2 lots of Advil Pediatric Drops Fever from Cold and Flu.

The recall only involves certain lots manufactured by Pfizer Pharmaceutical Company that were distributed for sale to various retailers in Canada. To date, no other countries, including the U.S., are impacted by the recall.

Pfizer is asking customers to stop using the recalled Advil medications and return them to their store of purchase for safe disposal. Wholesalers, retailers, and physicians’ offices have been instructed to remove all remaining recalled inventory from store and storage shelves.