US Drug Recall Register
Class III · Low risk Terminated Initiated Jul 6, 2017 (9 years ago)

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile…

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

Why it was recalled

Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point

What was recalled

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01

Recalling firm
Hospira Inc., A Pfizer Company
NDC code
0409-1140-01
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0980-2017

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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