Pfizer recalls 2 lots of migraine drug RELPAX over possible microbial contamination
Lots of Pfizer Inc's Relpax were distributed nationwide to wholesalers, retailers, hospitals and healthcare providers in the 50 states and Puerto Rico in June and July 2019.
New Delhi: Pfizer Inc. is voluntarily recalling 2 lots of RELPAX (eletriptan hydrobromide) 40 mg tablets as these product lots may not meet Pfizer's in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
The product is indicated for the acute treatment of migraine with or without aura in adults. RELPAX (eletriptan hydrobromide) 40 mg tablets are packaged in cartons.
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The recalled lots are No. AR5407, blister cards with six 40 mg tablets, and No. CD4565, boxes with two six-tablet blister cards. Both have an expiration date of February 2022. They were distributed nationwide to wholesalers, retailers, hospitals and healthcare providers in the 50 states and Puerto Rico in June and July 2019.
"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 a risk of temporary gastrointestinal distress without serious infection," reads the US FDA release.
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.
Pfizer notified its direct customers via a recall letter to arrange for a return of any recalled product.
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