US Drug Recall Register
Class III · Low risk Terminated Initiated Aug 28, 2018 (8 years ago)

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

Recalling firm
Pfizer Inc.
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1184-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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