Pfizer Inc. is voluntarily recalling two lots of RELPAX® (eletriptan hydrobromide) 40 mg tablets, lots AR5407 and CD4565, to the patient level. Replax is a selective serotonin inhibitor agonist used to treat migraine headaches. Pfizer Inc. initiated this recall 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. To date, Pfizer has not received any customer complaints or reports of adverse events related to this issue.