Pfizer Inc. is voluntarily recalling two lots of its migraine drug Relpax due to possible microbiological contamination.
Relpax, or eletriptan hydrobromide, is approved by the U.S. Food and Drug Administration to treat acute migraine with or without aura in adults.
The lots were recalled as they may not meet the New York-based pharmaceutical giant's in-house microbiological specification for the potential presence of the bacteria Genus Pseudomonas and Burkholderia. The recall covers Relpax 40-milligram tablets that were distributed in the U.S. and Puerto Rico between June and July.
Products contaminated with microorganisms put patients at risk of having bacteria spread from the gut to the bloodstream, which might result in serious, life-threatening infections, as well as temporary gastrointestinal distress without serious infection, according to an Aug. 15 recall notification issued by the FDA.
The FDA noted that these risks are low for the general population but could potentially cause serious adverse events including life-threatening infections for certain vulnerable patient populations, such as patients with compromised immune systems, cystic fibrosis and chronic granulomatous disease.
Pfizer has not yet received any customer complaints or reports of adverse events related to Relpax.