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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pfizer Inc.: Relpax (eletriptan HBr) Recalled for Packaging Error on Tablet Strength

Agency Publication Date: May 13, 2019
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Summary

Approximately 100,277 units of Relpax (eletriptan HBr) 40 mg tablets are being recalled due to an artwork error on one side of the outer carton. The packaging incorrectly states that each tablet contains 20 mg of eletriptan, when the tablets actually contain the full 40 mg dose. This recall affects various lots distributed nationwide with expiration dates ranging from October 2020 to November 2021.

Risk

The labeling error could lead patients to believe they are taking a lower dose of medication than prescribed, potentially resulting in confusion or improper dosing. While the medication inside the blister pack is the correct 40 mg strength, the conflicting information on the outer packaging presents a risk of medication mismanagement.

What You Should Do

  1. Check your Relpax 40 mg packaging for the following NDC numbers: 0049-2340-05 (12-count pack) or 0049-2340-45 (6-count pack).
  2. Examine the outer carton and blister cards for the following lot numbers and expiration dates: Lot W38322 (Exp 10/2020), Lot W98482 (Exp 03/2021), Lot W64062 (Exp 01/2021), Lot X27517 (Exp 03/2021), or Lot AJ3674 (Exp 11/2021).
  3. Compare the dosage strength printed on all sides of the carton; look for any side that incorrectly claims the tablets contain 20 mg instead of 40 mg.
  4. Contact your healthcare provider or pharmacist for guidance regarding the correct dosage and to discuss any concerns about the medication you have received.
  5. Return any unused product from the affected lots to your pharmacy for a refund and contact Pfizer Inc. for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall refund/guidance

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) 40 mg (12 tablets / 2 cards)
Model:
NDC 0049-2340-05
Lot Numbers:
W38322 (Exp 10/2020)
W98482 (Exp 03/2021)
Date Ranges: Expiration 10/2020, Expiration 03/2021
Product: Relpax (eletriptan HBr) 40 mg (6 tablets / 1 card)
Model:
NDC 0049-2340-45
Lot Numbers:
W64062 (Exp 01/2021)
X27517 (Exp 03/2021)
AJ3674 (Exp 11/2021)
Date Ranges: Expiration 01/2021, Expiration 03/2021, Expiration 11/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82715
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Roerig; Pharmacies
Manufactured In: Ireland, United States
Units Affected: 100277 tablets
Distributed To: Nationwide

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.