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The company is recalling the product because of potential microbiological contamination.
Pfizer announced on Aug. 15, 2019 that it was recalling two lots of Relpax (eletriptan hydrobromide) 40 mg tablets because of potential presence of Genus Pseudomonas and Burkholderia. According to the company, the lots, AR5407 and CD4565 may not meet the company’s in-house microbiological specifications.
The affected lots were packaged in cartons containing either six tablets or 12 tablets and were distributed in the United States and Puerto Rico from June–July 2019. Both lots have an expiration date of February 2022.
Relpax (eletriptan hydrobromide) is used to treat migraines in adults. The company states that consuming contaminated product could result in serious infections and temporary gastrointestinal distress. No reports of adverse events have been reported as of the date of the recall. Adverse events may be reported to FDA through the agency’s MedWatch program.