RELPAX Medication Recall Notice

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Archived recall notice

This recall was announced on August 14, 2019. The affected lots listed below had an expiration date of February 2022. This page is retained for historical reference and should not be interpreted as a new or current recall alert.

For current medication recall information, use the official U.S. Food and Drug Administration recall resources linked below.

Pfizer voluntarily recalled two lots of RELPAX® (eletriptan hydrobromide) 40 mg tablets because the lots might not have met the company's microbiological specifications.

 

Product

RELPAX® 40 mg tablets for the acute treatment of migraine in adults.

Affected lots

AR5407 and CD4565.

Recall date

August 14, 2019.

What patients should do

  1. Check the lot number on the medication package against the affected lots listed on this page.
  2. Contact your pharmacist or health care provider to confirm whether your medication is affected.
  3. Follow the return or replacement instructions provided by your pharmacy or the manufacturer.
  4. Report serious reactions or product-quality concerns through the FDA MedWatch program.
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Example of RELPAX 40 mg packaging. Packaging appearance alone does not confirm whether a lot was affected.

 

 

Why the medication was recalled

The two lots were recalled because of the potential presence of Pseudomonas and Burkholderia bacteria. Pfizer distributed the affected products in the United States and Puerto Rico from June through July 2019.

Patients should use the lot number and National Drug Code, rather than the package image alone, to identify the affected product.

Affected product details

RELPAX 40 mg products included in the 2019 recall
Carton NDC Lot number Expiration date Strength Package configuration
0049-2340-45 AR5407 February 2022 40 mg Carton containing six tablets: one blister card with six tablets.
0049-2340-05 CD4565 February 2022 40 mg Carton containing 12 tablets: two blister cards with six tablets each.

 

Official recall and safety resources

Use the FDA resources below for the original recall announcement, current drug recall information, and adverse-event reporting.

Read the original FDA recall announcement Search current FDA drug recalls Visit FDA MedWatch

 

 

Report a reaction or product-quality problem

Medical disclaimer: This page provides historical recall information and does not replace advice from a pharmacist, physician, or other qualified health care professional.