September 04, 2019
“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,” Pfizer wrote in an August 14, 2019, company announcement. “In addition, there is risk of temporary gastrointestinal distress without serious infection.”
The recall, which appeared in the September 4, 2019, US Food and Drug Administration (FDA) Enforcement Report, affects 40-mg Relpax packaged in:
- cartons containing six tablets (1 blister card x 6 tablets, NDC 0049-2340-45) from lot AR5407 (Exp. 2/22), and
- cartons containing 12 tablets (2 blister cards x 6 tablets, NDC 0049-2340-05) from lot CD4565 (Exp. 2/22).
The recalled tablets were distributed in June and July to wholesalers, retailers, hospitals, and healthcare providers throughout the United States and in Puerto Rico.
Pfizer voluntarily initiated the recall August 14, 2019. The FDA designated the recall Class II on August 28, 2019. The classification suggests use of the affected tablets could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.
Relpax is a prescription medication for the treatment of migraine headaches in adults.