The commission earlier Thursday issued a recall alert for the migraine medication, urging consumers to secure the product out of sight and reach of children and to contact Pfizer for a free child-resistant pouch to store the product. Pfizer said customers don't need to return the drug.
"Patients should be 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 said.
No incidents or injuries tied to the product have been reported, the commission said.
Nurtec ODT is manufactured by Biohaven Pharmaceutical Holding Co. Ltd., which Pfizer bought in October last year. The commission said its alert applies to 75-milligram, orally disintegrating Nurtec ODT tablets that are sold in cartons containing one blister card of 8 tablets.
The commission said the packaging issue affects about 4.2 million units of Nurtec ODT and likely an estimated 300,000 more units currently out in the marketplace.
As an interim measure, Pfizer has instructed pharmacists to place the non-child-resistant blister in a child-resistant vial prior to dispensing the medication to patients.
