Pfizer is recalling Advil liquid products for infants and young children due to the "potential risk of inconsistencies in dosing." Health Canada issued the product recall alert last Friday with a follow-up on Saturday.
Pfizer Consumer Healthcare is recalling 126 lots of Advil products because "clumps" of ibuprofen could form inside the bottle. This accumulation could result in lower or higher doses of the liquid products if they are not shaken well enough prior to usage. Below are the Advil liquid products being recalled:
- Advil Pediatric Drops (DIN 02242522)
- Children's Advil Cold (DIN 02248435)
- Children's Advil Fever from Colds or Flu (DIN 02328437)
- Children's Advil (DIN 02232297)
- Advil Pediatric Drops Fever from Colds or Flu (DIN 02328445)
"Lower doses may not be adequate in reducing the fever, leading to other health issues which could include, in rare instances, convulsions," says the alert, adding that higher doses are less common but could result in dizziness, drowsiness, vomiting, lowered breathing rates and even "ringing in the ears."
Despite the fact that the U.S. FDA and other federal health regulators have strengthened the safety warnings for painkillers because of increased risks for heart disease, the alert says these consequences are unlikely. This is due to the assumption that consumers always follow the label instructions saying products should always be shaken well before using.
However, Health Canada still advises consumers to stop using the affected products as a precaution and return them to drugstores. The agency also recommends that concerned consumers who might have given their children affected products should see their doctor.
"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," says David Lessard, Pfizer Global Supply's Quality and Compliance director.
Lessard adds that the company has worked swiftly to trace the cause. With the incident completely resolved, consumers can be sure that all of Advil products that are currently in production meet the company's strict product quality standards. Pfizer says no other products are affected in their voluntary recall.
In order to check if purchased Advil products at home, hospitals, clinics and pharmacies are affected, people can see the lot number located on the bottle's side. Apart from returning the affected products to a pharmacy, consumers call also call Pfizer for a full refund at 1-888-275-9938. The full list of the impacted lots can be found on the Pfizer website.
Photo : Tammra McCauley | Flickr
