Reported Sep 4, 2019 · Terminated

RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b)…

Pfizer Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pfizer Inc. · 235 E 42nd St · New York, NY · 10017-5703

Is this the product you have?

  • RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.
Lot codes and dates
    • Lot #: a) AR5407
    • Exp 2022 FEB
    • b) CD4565
    • Exp 2022 FEB
Amount recalled
a) 20,117 cartons; b) 2,502 cartons

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 20, 2023 · Data as of Sep 19, 7:21 PM UTC

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