Reported Sep 19, 2018 · Terminated

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira,…

Pfizer Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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?

  • Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile
  • Manufactured forHospira, Inc, Lake Forest, IL 60045 USA
  • NDC0409-1140-01
Lot codes and dates
  • Lot
    • DP602
    • 10/2018
Amount recalled
1,580 vials

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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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 26, 2020 · Data as of Sep 19, 6:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.