Pfizer is recalling more than four million packets of the prescription migraine medication Nurtec ODT due to the risk of poisoning to children due to non-compliance with child-resistant packaging safety requirements.
The company is recalling about 4.2 million units of Nurtec ODT (rimegepant) 75 mg orally disintegrating tablets, which are sold in eight-dose packs on a blister card, on Thursday, the US Consumer Product Safety Commission .us saying. Anyone affected will be able to get a free child-resistant bag to store the product, the commission said.
Prescription drugs must be in child-resistant containers under the Poison Prevention Packaging Act, the safety commission said.
«The packaging of the products is not child resistant, which poses a risk of poisoning if young children swallow the contents,» it warned.
Consumers were told to «immediately secure the recalled product out of the sight and reach of children and to contact Pfizer for a free child-resistant bag to store the product.»
Once consumers have secured the drug in the bag, they can continue to use it as directed, the commission said.
As of Thursday, no incidents related to the issue had been reported, the safety commission said.
Nurtec ODT shared the news of the recall on Twitter and posted a statement to its website saying that Pfizer had «recently determined that Nurtec ODT packaging does not meet child-resistant packaging requirements for oral prescription drugs, which could pose a risk of harm if the contents are swallowed by young children.»
While patients will still be able to keep the product once they have obtained child-resistant bags to store it in, Nurtec ODT noted that the safety commission «uses the term ‘recall’ to describe any repair, replacement, refund, or notice/warning program.»
Nurtec ODT said Pfizer was working to create new packaging for the migraine drug to meet child-resistant packaging requirements. In the meantime, he said pharmacists would place the blister packs in vials with child-resistant caps when filling patient prescriptions.
The drug was distributed in pharmacies across the country as a prescription drug from December 2021 to March 2023, the safety commission said.
Pfizer did not immediately respond to an overnight request for comment.