On the surface, a failure to comply with childproof packaging requirements may look like a major headache for Pfizer and its recently acquired migraine partner Biohaven. But there’s more to the story than a run-of-the-mill recall, the company says.
The U.S. Consumer Product Safety Commission (CPSC) has announced a recall of 4.2 million units of Pfizer and Biohaven’s migraine therapy Nurtec ODT. The effort specifically pertains to Nurtec ODT 75mg orally disintegrating tablets, which come in cartons containing a single blister card of 8 tablets. The blister card itself isn’t child-resistant, which could pose a risk of poisoning to young kids.
To date, no injuries have emerged in relation to the recall, Pfizer and CPSC have said.
Crucially, CPSC’s recall definition differs from that of the U.S. Food and Drug Administration, and the move doesn’t necessarily mean products are being pulled from shelves, Pfizer told Fierce Pharma.
The CPSC defines the term “recall” to describe “any repair, replacement, refund, or notice/warning program,” Pfizer explained in an emailed statement, noting “[t]his does not necessitate return of product.”
In Nurtec’s case, the remedy to the problem has been identified, the company said. Pfizer has instructed pharmacists to place the implicated blister cards in a child-resistant vial before the medicine is given to patients.
Consumers can continue to use the product as directed once it’s secured, CPSC explained.
Users of Nurtec ODT should “rest assured that there are no quality or safety issues nor health risks when they take the medicine as prescribed for its approved use,” Pfizer added in its statement.
The millions of products implicated in the pull were set to expire as late as June of 2026. They were sold at pharmacies across the country between December 2021 through March 2023 and were manufactured by Biohaven and Pfizer.
Pfizer explained that Biohaven tweaked the packaging for Nurtec ODT some months before their M&A deal last year. Pfizer determined independently that the packaging did not meet childproofing standards.
As a result, Pfizer reached out to CPSC and came up with the temporary pharmacy packaging solution to keep supplies on tap.
The migraine buyout is part of a broader plan for Pfizer to add $25 billion in risk-adjusted revenues by 2030 through business development, the company’s chief business innovation officer, Aamir Malik, told investors last spring.
Though not always tied to packaging, Pfizer has charted a fair number of recalls over the past year. Late last year, the company’s subsidiaries Hospira and Accord launched separate recalls over particulate concerns and a labeling issue, respectively.
Earlier in 2022, meanwhile, the company ran into repeat carcinogen concerns around several blood pressure medications in Canada and the U.S.