Pfizer Recalls Relpax® (eletriptan hydrobromide)

Date: 09/09/19

On August 15, 2019, the U.S. Food and Drug Administration (FDA) announced that Pfizer was recalling Relpax® (eletriptan hydrobromide) lots AR5407 and CD4565 to the consumer level due to potential for microbiological contamination.

The FDA press release states the following:

Pfizer Inc. is voluntarily recalling Relpax (eletriptan hydrobromide) 40 mg tablets, lots AR5407 and CD4565, to the patient level. 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. Please immediately check your medical supplies, quarantine any drug products impacted, and not administer them. 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 were distributed nationwide to wholesalers, retailers, hospitals and healthcare providers in the United States and Puerto Rico from June 2019 to July 2019. Anyone with an existing inventory of the lots which are being recalled, should stop use and distribution and quarantine immediately.

Review the FDA’s full press release on their website. 

For questions or concerns, please reach out to Envolve Pharmacy Solutions’ Pharmacy Department by calling 1-800-782-2221.