RecallDepth
Class III Terminated

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

Company
Pfizer Inc.
Recall Initiated
August 28, 2018
Posted
September 19, 2018
Recall Number
D-1184-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
1,580 vials
Firm Location
New York, NY, United States

Reason for Recall

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

Distribution

Nationwide USA

Lot / Code Info

Lot: DP602, 10/2018

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