The Food and Drug Administration (FDA) announced Thursday, August 15 that Pfizer has issued a voluntary recall for 6- and 12-tablet packages of migraine medicine because continued use could lead to serioues, life-threatening infections.
Pfizer Inc. issued the recall on RELPAX® (eletriptan hydrobromide) 40 mg tablets, lots AR5407 and CD4565, to the Patient level. Pfizer Inc. because these product lots may not meet Pfizer’s in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia.
“Individuals who consume oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream potentially resulting in serious, life- threatening infections. In addition, there is risk of temporary gastrointestinal distress without serious infection. For the general population these risks are low; for certain vulnerable patient populations (such as patients with compromised immune systems, cystic fibrosis and chronic granulomatous disease) there may be the potential for serious adverse events including life- threatening infections.”
RELPAX®(eletriptan hydrobromide) is indicated for the acute treatment of migraine with or without aura in adults.
RELPAX ® (eletriptan hydrobromide) 40 mg tablets are packaged in cartons as indicated below. The affected lots were distributed nationwide to wholesalers, retailers, hospitals, and healthcare providers in the United States and Puerto Rico from June 2019, to July 2019.
To date, Pfizer has not received any customer complaints or reports of adverse events related to this issue.
For more on the recall, click here