On 15 Aug 2019, Pfizer issued the voluntarily recalling of migraine headache medicine RELPAX® (eletriptan hydrobromide) 40 mg tablets, lots AR5407 and CD4565, to the Patient level. Pfizer initiated this recall because these product lots may not meet Pfizer’s in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia.
To date, Pfizer has not received any customer complaints or reports of adverse events related to this issue.
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 risk of temporary gastrointestinal distress without serious infection. 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.
The two lots of Relpax (eletriptan) were distributed throughout the U.S. and Puerto Rico in June and July.
In late April, Pfizer had recalled five lots of Relpax. In that case, it was because there was an artwork error on the secondary packaging indicating the meds were 20 mg tablets instead of 40 mg tablets.
Patients with the affected lots should return the medication to their pharmacy or contact Stericycle Inc. at 877-225-9750 for instructions on how to return it and be reimbursed.
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