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Migraine headache drug recalled after company finds possible microbial contamination

How FDA drug recalls work

The U.S. Food and Drug Administration regulates the safety of drugs, but sometimes a problem arises that triggers a recall. Here's how the recall process works and what you should do if a medicine you use is recalled.
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The U.S. Food and Drug Administration regulates the safety of drugs, but sometimes a problem arises that triggers a recall. Here's how the recall process works and what you should do if a medicine you use is recalled.

Pfizer recalled two lots of migraine drug Relpax after finding those lots “may not meet Pfizer’s in-house microbiological specification for the potential presence” of two kinds of bacteria.

That’s according to the Pfizer-written, FDA-posted recall notice.

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.

According to the notice, the risk is “bacterial dissemination from the gut to the bloodstream potentially resulting in serious, life-threatening infections. In addition, there is risk of temporary gastrointestinal distress without serious infection.”

Most healthy people aren’t at serious risk. But for people with damaged immune systems, cystic fibrosis and chronic granulomatous disease (which damages the immune system), “there may be the potential for serious adverse events including life-threatening infections,” Pfizer wrote.

Consumers, retailers or healthcare professionals with questions on returning their lots can call Stericycle at 877-225-9750.

To ask Pfizer medical questions about Relpax, call 800-438-1985, option No. 3, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.

To report a complaint or adverse event to Pfizer, call 800-438-1985, option No. 1, 24/7.

To report an adverse event to the FDA, click here to report online; click here to download a form; or call 800-332-1088 to request a reporting form.

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Relpax by Pfizer.jpg
A Six-tablet box of Relpax FDA

Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.
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