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).
Cite this: Anti-Migraine Drug Recalled Due to Potential Contamination - Medscape - Aug 19, 2019.