Pfizer Canada recalls certain Advil Pediatric Drops and Children’s Advil oral suspension products

The lots are being recalled as a precautionary measure because of a potential risk of inconsistencies in dosing of the product. "Clumps" of ibuprofen may form in the bottle and lead to higher or lower doses that are given to infants and children if it is not shaken well before each use.

No serious adverse events have been reported. However, as a precaution Pfizer is asking consumers to stop using these products and return the recalled product to their pharmacy for safe disposal. Parents who have given these products to their children and have concerns should consult with their health care practitioner.

This recall has been classified as a Type II, a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.

Lower doses may not be adequate in reducing the fever, leading to other health issues which could include, in rare instances, convulsions. Although unlikely, higher doses may lead to vomiting, drowsiness, dizziness, ‘ringing in the ears’ and decreased breathing rates.

The likelihood of these potential severe adverse consequences is remote as long as the product has always been shaken well before each use as per label instructions.

The issue was identified during routine stability testing, in which products are tested to ensure that they maintain their integrity over time and as they reach their expiration dates. The issue was caused by a change to an emulsifying ingredient (xanthan gum) from one of Pfizer’s suppliers, which allowed ibuprofen in the liquid suspension to separate over time in the affected products.

Pfizer Global Supply director of quality & compliance David Lessard said: "Our top priority is delivering safe and top quality products that Canadians can trust.

"As soon as the product issue was identified, we took action to investigate any potential safety issues associated with the product. We also worked to track the cause, and replaced the source of one ingredient that was found to be the cause of the issue. The situation is now fully resolved, and parents can be confident that all Advil® Pediatric Drops and Children’s Advil® Ibuprofen Oral Suspension products in production meet Pfizer’s stringent quality requirements."

The voluntary recall involves wholesalers, retailers, physicians’ offices and consumers and is being conducted in collaboration with Health Canada. No other products have been affected or are involved in this voluntary recall.