Pfizer (PFE) is recalling 4.2 million units of its migraine treatment for failing to meet child resistant packaging requirements.
The recall involves the prescription drug Nurtec ODT 75 mg orally disintegrating tablets sold in cartons containing one blister card of 8 tablets, according to a filing with the U.S. Consumer Product Safety Commission.
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The drug was once endorsed by media personality Khloé Kardashian.
The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children, the CPSC said.
The tablets are in a non-child resistant blister card packaged in a carton that includes the name of the product, dosage strength, NDC number and expiration date.
The dosage strength and expiration date are printed or stamped on the blister card.
Consumers should immediately secure the recalled product out of the sight and reach of children and contact Pfizer for a free child resistant pouch to store the product, the CPSC said.
The recalled prescription drugs must be in child resistant packaging as required by the Poison Prevention Packaging Act, which was enacted in 1970 to ensure child safety by preventing accidental ingestion of harmful chemicals.
Pfizer said in a statement that it is "is quickly working to create new packaging for Nurtec ODT to comply with the necessary child-resistant packaging requirements."
Patients Continue to Have Access to Drug
"In the meantime, pharmacists will place Nurtec ODT blister packages into vials with child-resistant lids when filling patient prescriptions." the company said. "To date, we have not identified any adverse events or safety concerns associated with this child-resistant packaging issue."
Pfizer said that patients will continue to have access to Nurtec ODT through their pharmacy.
The recall notice is related to the packaging of the treatment, the company said, and does not change the established safety profile of the drug when used as prescribed for its intended uses.
Nurtec ODT orally disintegrating tablets is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine.
The drug was approved by the U.S. Food & Drug Administration in 2020. It was made by Biohaven Pharmaceutical, which Pfizer acquired last year in an $11.6 billion all-cash takeover.
Kardashian, who suffers from migraines, said in a 2020 endorsement statement that Nurtec "worked fast and allowed me to get back to normal so that I could take back my day."
Roughly 39 million people in the United States and 1 billion people worldwide have migraine, making it the third most common illness in the world.
In January, Pfizer posted stronger-than-expected fourth quarter earnings, but issued a softer 2023 growth forecast due to waning sales for its Covid treatments.
