Is Argatroban recalled?

4 FDA recalls mention Argatroban. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Argatroban.

Class III · Low risk Terminated Aug 28, 2018

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

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

Pfizer Inc. D-1184-2018

Class III · Low risk Terminated Jul 6, 2017

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited…

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

Hospira Inc., A Pfizer Company NDC 0409-1140-01 D-0980-2017

Class II · Moderate risk Terminated Jun 17, 2016

ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS…

Reason CGMP Deviations

Teva North America NDC 0703-0020-31 D-1494-2016

Class I · High risk Terminated Dec 2, 2011

Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10…

Reason A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible…

Eagle Pharmaceuticals Inc. NDC 42367-203-07 D-1429-2012

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

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited…

ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS…

Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10…

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