Nurtec ODT recall: Pfizer to develop new packaging after product didn't meet child-resistant requirements

Pharmaceutical giant Pfizer is developing new packaging for one of its prescription drugs after discovering it didn't meet child-resistant requirements, and could pose a poisoning risk. 

Pfizer is recalling 4.2 million Nurtec ODT 75 mg orally disintegrating tablets sold in cartons containing one blister card of eight tablets, according to a notice from the Consumer Product Safety Commission (CPSC), posted Thursday. 

The drug, according to Pfizer, is intended for the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults.

The packaging is not child resistant, as required by the Poison Prevention Packaging Act (PPPA), which poses "a risk of poisoning if the contents are swallowed by young children," the CPSC said.  

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To date, there haven't been any injuries or illnesses tied to the packaging, which was manufactured by Biohaven Pharmaceuticals Inc. Pfizer acquired Biohaven in October 2022.

The company learned that Biohaven had updated the Nurtec packaging in late 2021 but that it hadn't been tested for child resistance, a spokesperson for Pfizer told FOX Business. The company informed the CPSC of this issue and initiated a test of the packaging. Last month, the company discovered that it didn't meet the CPSC's requirements, alerted the agency and temporarily paused distribution. 

"Patients 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," the company said in a statement. 

The company continued saying that the CPSC uses the term recall to "describe any repair, replacement, refund, or notice/warning program." 

The notice doesn't mean consumers need to return the product, Pfizer said. 

In the interim, while the packaging is being updated to meet PPPA requirements for oral prescription drugs, Pfizer said it has "instructed pharmacists to place the blister in a child-resistant vial prior to dispensing to patients."

Meanwhile, patients with the recently recalled prescribed medicine are told to "immediately secure the recalled product out of the sight and reach of children," the CPSC said. 

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Pfizer said customers can call the company in order to get a child-resistant pouch to store the product free of charge. 

Currently, there is estimated to be about 300,000 units still circulating, a spokesperson for Pfizer said.

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"Once the product is secured, consumers can continue to use it as directed," the CPSC said. 

Pharmacies nationwide prescribed the medicine to patients between December 2021 through March 2023.