NEW YORK CITY (dpa-AFX) - The U.S. Food and Drug Administration or FDA announced on its website that pharma major Pfizer, Inc. issued recall of certain drugs meant to treat acute migraine in adults for concerns over bacteria infection.
The pharma company is recalling two lots of Relpax (eletriptan hydrobromide) 40 mg tablets for potential presence of Genus Pseudomonas and Burkholderia bacteria. The recall affects product lots AR5407 and CD4565 of the tablet. These were sold in the United States and Puerto Rico from June 2019, to July 2019.
Pfizer warned that consumption of these can cause bacterial dissemination from the gut to the bloodstream that may result in in serious, life- threatening infections. They are also at risk of temporary gastrointestinal distress without serious infection.
However, Pfizer said so far it has not received any customer complaints or reports of adverse events related to this issue.
Patients with the affected lots have been advised to return the product to their pharmacy and get refund. Pfizer has also asked distributors to stop selling these tablets immediately.
Previously, Pfizer's Consumer Healthcare had recalled a total of seven lots of ThermaCare HeatWrap product in two recalls dated April 2019 and November 2018 due to higher cell temperature than specified and leaking ingredients, respectively.
Nearly a year ago, Pfizer's Consumer Healthcare recalled one lot of Children's Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle as a faulty dosage cup could lead to potential overdose.
Copyright RTT News/dpa-AFX
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