Medication Monitor

Generic Name (Trade Name—Company)
August 21, 2019

Eletriptan hydrobromide

Two lots of 40-mg tablets recalled for microbiological contamination

Pfizer is voluntarily recalling eletriptan hydrobromide 40-mg tablets, lots AR5407 and CD4565, to the patient level 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 GI 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 40-mg tablets are packaged in cartons. The affected lots were distributed nationwide to wholesalers, retailers, hospitals, and health care 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.