DETROIT – A drug used for the treatment of migraines in adults is being recalled because it could be contaminated with microorganisms that could cause a serious, life-threatening infection.
Pfizer Inc. issued a voluntary nationwide recall Wednesday for two lots of Relpax (eletriptan hydrobromide) 40-milligram tablets due to the potential contamination.
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The lots are AR5407 and CD4565. The products may not meet Pfizer's in-house microbiological specification for the potential presence of genuses Pseudomonas and Burkholderia.
According to the Federal Drug Administration, people who consume contaminated products are at risk of serious, life-threatening infections. There is also risk of temporary gastrointestinal distress without serious infection.
Those with compromised immune systems, cystic fibrosis and chronic granulomatous disease could face serious, life-threatening infections. Pfizer has not received any customer complaints yet.
Relpax is used for the actue treatment of migraine with or without aura in adults. The affected lots were distributed nationwide to wholesalers, retailers, hospitals and health care providers from June until July.
Patients with the affected lots should return the product to their pharmacy or contact Stericycle Inc. at 877-225-9750 for instructions on how to return their product and obtain reimbursement for their cost.
To read more on the FDA website, click here.