Pfizer Inc. Issues a Voluntary Nationwide Recall for 2 Lots of RELPAX®

Published: 08/15/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Pfizer Inc. is voluntarily recalling RELPAX® (eletriptan hydrobromide) 40 mg tablets, lots AR5407 and CD4565, to the Patient level. Pfizer Inc. 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.

Individuals who consume oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream potentially resulting in serious, li

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