Home / Recalls / Hospira Inc., A Pfizer Company / D-0980-2017

D-0980-2017 Class III Terminated

Recalled by Hospira Inc., A Pfizer Company — Lake Forest, IL

Recall Details

Product Type: Drugs
Report Date: July 26, 2017
Initiation Date: July 6, 2017
Termination Date: September 10, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 701 vials

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot: DP601, exp 10/2018

Other recalls by Hospira Inc., A Pfizer Company

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D-0480-2017 Class II — METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Con (February 10, 2017)
D-0638-2017 Class I — Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - N (January 24, 2017)
Z-1682-2017 Class II — Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of (December 30, 2016)
D-0096-2017 Class II — Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL (September 16, 2016)
D-0097-2017 Class II — Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Mu (September 16, 2016)
D-0218-2017 Class I — Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single- (August 4, 2016)
Z-2790-2016 Class II — Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 1 (July 28, 2016)