Children's Advil Recalled In Canada Over Dosage Concerns

Friday, February 19, 2016
FDA Recalls

U.S. drug maker Pfizer announced this week that it was recalling tens of thousands of packages of infant and children’s Advil from store shelves in Canada, after analysis showed ingredient spoiling may lead to higher or lower dosages than intended.

The move comes during the heart of cold and flu season, when parents rely most on the medications to prevent family illness.

Pfizer’s recall includes:

  • Children's Advil (97 batches)
  • Advil Pediatric Drops (20 batches)
  • Children's Advil Fever from Colds or Flu (4 batches)
  • Children's Advil Cold (3 batches)
  • Advil Pediatric Drops Fever from Colds or Flu (2 batches)

As is common practice in the industry, Pfizer retains a portion of their shipped products for testing, in order to ensure that they remain safe and effective through the date of expiration.

In this case, the company found during testing that the active ingredient ibuprofen could clump together before expiration. This could cause some patients to receive higher-than-normal dosages, while others could receive lower-than-normal dosages.

The problem of ingredient clumping is usually eliminated if the drug is shaken thoroughly; however, dangers increase with children and infants.

Pfizer estimated the chances of serious reactions were remote, but warned that reduced dosages could lead to convulsions from children not receiving sufficient amounts to fight their fever. Higher than normal dosages could cause shortness of breath, nausea, vomiting, dizziness, tiredness or ringing in the ears.

The company claims it has identified the source of the defect and that the issue has been remedied.

The Children’s Advil recall comes just weeks after a similar product, Mucinex, recalled its grape-flavored formula in U.S. stores due to mislabeled dosing cups.

For more news and updates on these recalls, check back with DrugNews.

 

Sources:

Palmer, E. Pfizer pulls tens of thousands of bottles of children's and infants' Advil in Canada FiercePharma. (February 16, 2016). Retrieved from www.fiercepharma.com

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