DrugSep 23, 2015
Hospira Ketamine Hydrochloride Injection, USP (100 mg/mL) recall — FDA D-0418-2015
Defective Container: There were customer complaints of cracked and leaking glass vials.
Class IIFDA: TerminatedHospira Inc.
Recall history in this database
Classification mix: Class II: 110, Class I: 31, Class III: 10.
DrugJul 22, 2015
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M recall — FDA D-1241-2015
Crystallization; identified as calcium salt of Ketorolac
Class IIFDA: OngoingHospira Inc.
DrugJul 22, 2015
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M recall — FDA D-1242-2015
Crystallization; identified as calcium salt of Ketorolac
Class IIFDA: OngoingHospira Inc.
DrugJul 15, 2015
Hospira Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM recall — FDA D-1232-2015
Failed pH Specifications: 12 month stability testing
Class IIIFDA: TerminatedHospira Inc.
DrugJul 15, 2015
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use recall — FDA D-1216-2015
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Class IFDA: TerminatedHospira Inc.
DrugJun 3, 2015
Hospira LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag recall — FDA D-1108-2015
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Class IFDA: TerminatedHospira Inc.
DrugMay 20, 2015
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL recall — FDA D-1076-2015
Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in…
Class IFDA: TerminatedHospira Inc.
DrugMay 13, 2015
Hospira 0.9% Sodium Chloride Injection, USP, 250 mL recall — FDA D-0976-2015
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Class IFDA: TerminatedHospira Inc.
DrugApr 29, 2015
Hospira 0.9% Sodium Chloride Injection, USP, 250 mL recall — FDA D-0969-2015
Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Class IFDA: TerminatedHospira Inc.
Medical DeviceApr 29, 2015
Hospira The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer recall — FDA Z-1517-2015
The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Class IIFDA: TerminatedHospira Inc.
Medical DeviceApr 29, 2015
Hospira The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or recall — FDA Z-1518-2015
The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Class IIFDA: TerminatedHospira Inc.
DrugApr 15, 2015
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL recall — FDA D-0433-2015
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Class IFDA: TerminatedHospira Inc.
DrugMar 25, 2015
DEXTROSE 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC recall — FDA D-0417-2015
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Class IIFDA: TerminatedHospira Inc.
Medical DeviceMar 4, 2015
Hospira The Plum A+ Infusion System is designed to meet the fluid delivery requirements of recall — FDA Z-1073-2015
One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Class IFDA: TerminatedHospira Inc.
Medical DeviceMar 4, 2015
Hospira The Plum A+ Infusion System is designed to meet the fluid delivery requirements of recall — FDA Z-1074-2015
One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Class IFDA: TerminatedHospira Inc.
Medical DeviceMar 4, 2015
Hospira The Plum A+ Infusion System is designed to meet the fluid delivery requirements of recall — FDA Z-1072-2015
One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Class IFDA: TerminatedHospira Inc.
Medical DeviceMar 4, 2015
Hospira The Plum A+ Infusion System is designed to meet the fluid delivery requirements of recall — FDA Z-1071-2015
One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Class IFDA: TerminatedHospira Inc.
Medical DeviceMar 4, 2015
Hospira The Plum A+ Infusion System is designed to meet the fluid delivery requirements of recall — FDA Z-1075-2015
One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Class IFDA: TerminatedHospira Inc.
DrugFeb 25, 2015
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion recall — FDA D-0389-2015
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class IFDA: TerminatedHospira Inc.
DrugFeb 25, 2015
LIDOCAINE HYDROCHLORIDE 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose recall — FDA D-0391-2015
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Class IFDA: TerminatedHospira Inc.
DrugFeb 25, 2015
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial recall — FDA D-0388-2015
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class IIFDA: TerminatedHospira Inc.
DrugFeb 25, 2015
Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial recall — FDA D-0390-2015
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class IIFDA: TerminatedHospira Inc.
DrugFeb 25, 2015
Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial recall — FDA D-0387-2015
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class IIFDA: TerminatedHospira Inc.
DrugFeb 11, 2015
LIDOCAINE HYDROCHLORIDE 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL recall — FDA D-0382-2015
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Class IFDA: TerminatedHospira Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Hospira, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.