Pfizer is recalling two lots of eletriptan hydrobromide (Relpax) 40-mg tablets because of potential contamination with Pseudomonas and Burkholderiabacteria, the company has announced.
The drug is indicated for the acute treatment of migraine with or without aura in adults.
Patients who consume oral products contaminated with microorganisms are at risk for bacterial dissemination from the gut to the bloodstream, which can result in serious, life-threatening infections, the company cautions. There is also a risk for 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,” the company noted in a press release.