Pfizer Recalls Relpax for Migraine Due to Potential Microbiological Contamination

Pfizer is voluntarily recalling its eletriptan hydrobromide (Relpax) 40 mg tablets, lots AR₅₄₀₇ and CD_4565, which are indicated for the acute treatment of migraine with or without aura in adults, because of in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia.

Those with an existing inventory of the lots that are being recalled should stop use and distribution and quarantine immediately. The 2 lots are packaged in cartons indicated as follows: Carton NDC: 0049-2340-45, lot number: AR₅₄₀₇, expiration date, February 2022, strength: 40 mg, count: carton containing 6 tablets (1 blister card x 6 tablets); Carton NDC: 0049-2340-05, lot number: CD₄₅₆₅, expiration date, February 2022, strength: 40 mg, count: carton containing 12 tablets (2 blister cards x 6 tablets).

“Pfizer completed a Health Hazard Assessment, which concluded that the use of the impacted product has an unlikely probability of being associated with adverse events such as a decrease in therapeutic efficacy or infections in the general population,” the drug recall letter stated.^{1 “}However, use of the impacted product in certain patient populations may be severe to life-threatening. The potential risk to a patient arising from this issue is considered to be low for the general population and high for immunocompromised patients.”

The recall stated that 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. Additionally, there’s a risk of temporary gastrointestinal distress without serious infection.

READ MORE: Christopher Gottschalk, MD discusses how CGRP medications have improved the migraine treatment landscape.

The risks are low for the general population, however, for certain vulnerable populations with compromised immune systems, cystic fibrosis, and chronic granulomatous disease, there may be the potential for serious adverse events. To date, there have been no customer complaints or reports of adverse events related to the potential contamination.

The affected lots were distributed nationwide to wholesalers, retailers, hospitals, and healthcare providers in the United States and Puerto Rico from June 2019 through July 2019.

“Pfizer Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” the FDA announcement stated.² “Pfizer Inc. has notified its direct customers via a recall letter to arrange for return of any recalled product.”

Patients taking Relpax should consult with their healthcare provider or pharmacy to determine if they have the affected product lots, and if so, should return the product to their pharmacy or Stericycle Inc. for instructions on how to return their product and obtain reimbursement for their cost.

Adverse reactions or problems with the use of Relpax should be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or fax.

REFERENCES

1. Pfizer. Urgent: Drug Recall, RELPAX® (eletriptan HBr) tablets. Aug. 14, 2019. https://www.pfizermedicalinformation.com/sites/default/files/attachments/replax_recall_letter_august_14_2019_0.pdf. Accessed Aug. 19, 2019.

2. Pfizer Inc. Issues A Voluntary Nationwide Recall For 2 Lots of RELPAX® (eletriptan hydrobromide) 40 mg Tablets Due to Potential Microbiological Contamination of Non-Sterile Products [news release]. Pfizer Inc.: New York, NY; Aug. 14, 2019.