Anti-Migraine Drug Recalled Due to Potential Contamination

Megan Brooks

August 19, 2019

Pfizer is recalling two lots of eletriptan hydrobromide (Relpax) 40-mg tablets because of potential contamination with Pseudomonas and Burkholderia bacteria, the company has announced.

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

Patients who consume oral products contaminated with microorganisms are at risk for bacterial dissemination from the gut to the bloodstream, which can result in serious, life-threatening infections, the company cautions. There is also a risk for 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," the company noted in a press release.

To date, Pfizer has not received any customer complaints or reports of adverse events related to this recall. 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.

Table. Specifications for Affected Lots

Carton NDC Lot # Exp Date Strength Configuration
0049-2340-45 AR5407 Feb 2022 40 mg Carton w/6 tablets (1 blister card x 6 tablets)
0049-2340-05 CD4565 Feb 2022 40 mg Carton w/12 tablets (2 blister cards x 6 tablets)

 

Pfizer has notified its direct customers via a recall letter to arrange for return of any recalled product. Anyone with an existing inventory of the recalled product should stop use and distribution and quarantine immediately.

Healthcare professionals, retailers, and hospitals that have dispensed the product to patients are asked to notify these patients regarding the recall.

For additional assistance, call Stericycle at 877-225-9750 (Monday through Friday, 8:00 AM to 5:00 PM ET). For medical questions regarding this recall, contact Pfizer Medical Information at 800-438-1985, option 3 (Monday through Friday 9:00 AM to 5:00 PM ET).

For more Medscape Neurology news, join us on Facebook and Twitter

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....

Recommendations