Migraine Med Pulled Over Label Error

A label error concerning dosage strength has prompted Pfizer Inc. to recall five lots of 40-mg Relpax (eletriptan hydrobromide) tablets, according to the May 22, 2019, US Food and Drug Administration (FDA) Enforcement Report.

“An artwork error on the secondary packaging of Relpax 40-mg tablets indicates that each tablet contains eletriptan hydrobromide equivalent to 20-mg eletriptan, instead of 40-mg, on one side of the carton,” the report stated. 

The recall affects Relpax 40 mg in 12-tablet blister packs (packaged in two cards containing six tablets each, NDC 0049-2340-05) from lots W38322 (Exp. 10/20) and W98482 (Exp. 3/21). Also recalled is Relpax 40 mg in 6-tablet blister packs (packaged in one card containing six tablets, NDC 0049-2340-45) from lots W64062 (Exp. 1/21), X27517 (Exp. 3/21), and AJ3674 (Exp. 11/21). The tablets were distributed by Roerig, a division of Pfizer, throughout the United States.  

Pfizer voluntarily initiated the recall April 29, 2019. The FDA designated the recall Class III on May 13, 2019, suggesting use of the affected product is unlikely to cause adverse health consequences. 

Relpax is a prescription medication for the treatment of migraine headache. 

—Jolynn Tumolo