Medication Recall

Pfizer Inc. Issues a Voluntary Nationwide Recall for RELPAX® (eletriptan hydrobromide) 40 mg Tablets

 

Image of Relpax front of box

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.

RELPAX®(eletriptan hydrobromide) is indicated for the acute treatment of migraine with or without aura in adults.

RELPAX ® (eletriptan hydrobromide) 40 mg tablets are packaged in cartons as indicated below. 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.

Carton NDC

Lot
Number

Expiration
Date

Strength

Configuration/Count

0049-2340-45

AR5407

2022 FEB

40 mg

Carton containing 6 tablets (1 blister card x 6 tablets)

0049-2340-05

CD4565

2022 FEB

40 mg

Carton containing 12 tablets (2 blister cards x 6 tablets)

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product lots.

Patients with the affected lots should return the product to their pharmacy or contact Stericycle Inc. at 877-225-9750 for instructions on how to return their product and obtain reimbursement for their cost.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.