- Pfizer last week issued a major recall of 126 lots of children's Advil in Canada due to concerns of inconsistent dosing in pediatric drops and oral suspension products.
- During routine stability testing, Pfizer discovered the products may "clump" in the bottle, inadvertently leading to higher or lower doses when administered to infants or children if not shaken prior to use.
- The clumping problem was traced to a change in the emulsifying agent (xanthan gum) used by one of Pfizer's suppliers. This caused the ibuprofen in liquid suspension form to separate over time.
Pfizer voluntarily recalled the products, which included Children's Advil, Advil Pediatric Drops, and other sub-brands, after identifying the dosing flaw. The recall extends to physicians' officers and consumers, as well as retailers.
This is the second large-scale recall of children's cold medicine this flu season. Last month, Perrigo recalled five of it generic version of grape-flavored Mucinex because the dosing cups for the medicine may have been mis-marked.
The recall was classified as a Type II recall where the use of a flawed product may cause adverse health events but the probability is considered remote.
As FiercePharma Manufacturing notes, the last major Advil recall was several years ago, in 2012.