Recall – two lots of RELPAX 40 mg Tablets – potential microbiological contamination of non-sterile products

Aug. 16, 2019
Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately.

The Food and Drug administration, in a safety alert, has announced Pfizer Inc.’s voluntarily recall of RELPAX (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 gastrointestinal distress without serious infection.

RELPAX is indicated for the acute treatment of migraine with or without aura in adults.

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.

RELPAX 40 mg tablets are packaged in cartons and affected lots were distributed nationwide to wholesalers, retailers, hospitals, and healthcare providers in the U.S. and Puerto Rico from June 2019, to July 2019.

Pfizer Inc. has notified its direct customers via a recall letter to arrange for return of any recalled product. Anyone with an existing inventory of the lots should stop use and distribution and quarantine immediately. Inform healthcare professionals in your organization of this recall. For retailers, hospitals, or healthcare providers that have dispensed product to patients, please notify these patients regarding the recall. For additional assistance, FDA says to call Stericycle at 877-225-9750 (Monday through Friday, 8 a.m. to 5 p.m. ET).

If you have received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check if you have received any of the affected product lots above. If you have any of the affected product lots in your possession, please contact your healthcare provider to return the product to them.