Pfizer Recalls Two Lots of Migraine Drug Relpax for Potential Microbiological Contamination

Pfizer has issued a voluntary recall to the patient level of two lots of Relpax (eletriptan hydrobromide) 40 mg tablets, a drug to treat migraines, for potential microbiological contamination. Pfizer says it initiated the recall because these product lots (AR5407 and CD4565) may not meet Pfizer’s in-house microbiological specifications for the potential presence of Genus Pseudomonas and Burkholderia.

The affected lots were distributed nationwide to wholesalers, retailers, hospitals, and healthcare providers in the United States and Puerto Rico from June 2019 to July 2019.

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. There is also a risk of temporary gastrointestinal distress without serious infection. To date, Pfizer says it has not received any customer complaints or reports of adverse events.

Pfizer says this recall is being executed with the knowledge of the US Food and Drug Administration (FDA).

Source: Pfizer and FDA

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