Two lots of migraine medication have been recalled
Pfizer has volountarily recalled the migraine medication Relpax because of the potential presence of Pseudomonas and Burkholderia.
Two lots of the migraine medication, Relpax (eletriptan hydrobromide) 40mg tablets have been voluntarily recalled in the US and Puerto Rico due to the potential presence of Genus Pseudomonas and Burkholderia.
According to Pfizer, the manufacturer of the medication, the lots AR5407 and CD4565 may not meet the company’s in-house microbiological specifications.
The affected lots of Relpax were distributed nationwide to wholesalers, retailers, hospitals and healthcare providers”
In its recall statement to the US Food and Drug Administration (FDA), the company has advised that 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.
The affected lots of Relpax were distributed nationwide to wholesalers, retailers, hospitals and healthcare providers from June 2019, to July 2019.
“Pfizer Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” the company said in its recall statement. “Pfizer Inc. has notified its direct customers via a recall letter to arrange for return of any recalled product.”
Patients who own affected lots have been advised to return the product to their pharmacy.