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Hospira Inc. A Pfizer Recalls
10 recalls on record · September 21, 2016 to March 14, 2018 · Drugs, Medical Devices
Recalls by year
16
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 14, 2018DrugsFDA
Hospira Inc. A Pfizer Company recalls Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, I
Hazard: Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
July 26, 2017DrugsFDA
Hospira Inc., A Pfizer Company recalls Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma L
Hazard: Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
June 21, 2017DrugsFDA
Hospira Inc., A Pfizer Company recalls Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC
Hazard: GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
April 12, 2017DrugsFDA
Hospira Inc., A Pfizer Company recalls Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous
Hazard: Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
April 5, 2017Medical DevicesFDA
Hospira Inc., A Pfizer Company recalls Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of thera
Hazard: Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss results in battery power operation.
March 1, 2017DrugsFDA
Hospira Inc., A Pfizer Company recalls METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc
Hazard: Lack of Sterility Assurance: customer report of leaking bag
December 28, 2016DrugsFDA
Hospira Inc., A Pfizer Company recalls Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, H
Hazard: Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
October 19, 2016DrugsFDA
Hospira Inc., A Pfizer Company recalls Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc.
Hazard: Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
October 19, 2016DrugsFDA
Hospira Inc., A Pfizer Company recalls Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, I
Hazard: Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
September 21, 2016Medical DevicesFDA
Hospira Inc., A Pfizer Company recalls Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combinati
Hazard: Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.