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Pfizer recalls RELPAX tablets

The products may be contaminated with Genus Pseudomonas and Burkholderia

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Photo source: FDA
Pfizer is recalling two lots (lAR5407 and CD4565) of RELPAX (eletriptan hydrobromide) tablets used for acute treatment of migraine with or without aura in adults.

These products may not meet Pfizer’s in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia.

Consuming oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream potentially resulting in serious, life- threatening infections.

Pfizer says it has not received any customer complaints or reports of adverse events to date.

The 40 mg tablets have an expiration date of February 2022, and come in cartons containing 6 and 12 tablets.

The recalled products were distributed nationwide to wholesalers, retailers, hospitals, and healthcare providers in the U.S. and Puerto Rico from June 2019, to July 2019.

What to do

Customers who purchased the recalled products should stop using them and return the, to their pharmacy or contact Stericycle at (877) 225-9750 for instructions on how to return the product and obtain reimbursement.

 

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