The recalled products include Advil Pediatric Drops, Children’s Advil Cold, Children’s Advil fever from Colds or Flu, Children’s Advil and Advil Pediatric Drops Fever from Colds or Flu.
This is a Class 2 recall, meaning the use of, or exposure to, a product may cause temporary adverse health consequences, or where the probability of adverse side effects or serious health risks is remote.
The products are being recalled due to an inconsistency in the amount of product in the given dose. According to Health Canada, as reported in Morning Star, “Clumps” of ibuprofen may form in the bottle and can lead to higher or lower doses given to infants and children if it is not shaken well before each use.
CTV News Canada is reporting the alert also noted that “Lower doses may not be adequate in reducing the fever, leading to other health issues which could include, in rare instances, convulsions.” The alert added, Although unlikely, higher doses may lead to vomiting, drowsiness, dizziness, ‘ringing in the ears’ and decreased breathing rates.”
And even while shaking the product well before dosing is suggested to break up any clumps, Health Canada is recommending that consumers quit using these products and return them to their pharmacy.
According to Pfizer’s website, the problem was identified during routine stability testing. This is done to ensure a product will maintain its stability until it reaches its expiration date. The issue was caused by a change in an emulsifying ingredient (xanthan gum) from one of Pfizer’s suppliers. The change caused the ibuprofen in the liquid suspension to separate out over time.
This recall affects wholesalers, retailers, physicians’ offices and consumers and is being done in collaboration with health Canada, says Pfizer. For a complete list of the recalled products and their lot numbers, consumers can go to the Healthy Canada website. To communicate with Pfizer directly, consumers can call Pfizer at 1-888-275-9938 for a full refund.
