Pfizer has 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.
The drugmaker is voluntarily recalling 40 mg tablets, lots AR5407 and CD4565, due to the the potential presence of Genus Pseudomonas and Burkholderia.
The affected lots were distributed nationwide to wholesalers, retailers, hospitals, and healthcare providers in the United States and Puerto Rico from June 2019 to July 2019. To date, Pfizer has not received any customer complaints or reports of adverse events related to this issue.
This is Pfizer's second Relpax recall – back in April, Pfizer had recalled five lots of Relpax due to a labelling error on secondary packaging indicating that the meds were 20 mg tablets instead of 40 mg tablets.
Read the recent press release on the FDA site