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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pfizer Inc.: RELPAX (eletriptan HBr) Tablets Recalled for Microbial Contamination

Agency Publication Date: August 23, 2019
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Summary

Pfizer Inc. is recalling 22,619 cartons of RELPAX (eletriptan HBr) 40 mg tablets because they may be contaminated with Burkholderia and Pseudomonas bacteria. The recall includes 6-count and 12-count cartons distributed across the United States and Puerto Rico. Consumers who have these migraine medications should check their packaging immediately for specific lot numbers and expiration dates. If you have the affected medicine, you should contact your healthcare provider or pharmacist for guidance on a replacement and return the product to your pharmacy for a refund.

Risk

The tablets may contain Burkholderia and Pseudomonas bacteria, which can cause serious, life-threatening infections in people with compromised immune systems or certain underlying health conditions. While no injuries have been reported, these bacteria can lead to pneumonia or blood infections if ingested or handled by vulnerable individuals.

What You Should Do

  1. Check your RELPAX (eletriptan HBr) 40 mg tablet packaging for the following identifying information: 6-count cartons (NDC 0049-2340-45) with lot number AR5407 and expiration date 2022 FEB, or 12-count cartons (NDC 0049-2340-05) with lot number CD4565 and expiration date 2022 FEB.
  2. If your medication matches the affected lot numbers and expiration dates, stop using the product immediately.
  3. Contact your healthcare provider or pharmacist to discuss your treatment and arrange for a replacement prescription.
  4. Return any unused RELPAX from the affected lots to your pharmacy to receive a full refund.
  5. Contact Pfizer Inc. at 1-800-438-1985 for further instructions or to report any adverse reactions.
  6. For additional questions or to report safety concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and Healthcare Consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: RELPAX (eletriptan HBr) tablets, 40 mg (6-count)
Model:
NDC 0049-2340-45
Lot Numbers:
AR5407 (Exp 2022 FEB)
Date Ranges: Exp 2022 FEB
Product: RELPAX (eletriptan HBr) tablets, 40 mg (12-count)
Model:
NDC 0049-2340-05
Lot Numbers:
CD4565 (Exp 2022 FEB)
Date Ranges: Exp 2022 FEB

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83533
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Pharmacies
Manufactured In: Ireland, United States
Units Affected: a) 20,117 cartons; b) 2,502 cartons
Distributed To: Nationwide
Agency Last Updated: August 28, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.