Hospira Recalls
257 recalls on record · June 20, 2012 to May 31, 2017 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 24, 2014DrugsFDA
Hospira Inc. recalls Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tam
Hazard: Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
December 17, 2014DrugsFDA
Hospira Inc. recalls Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per
Hazard: Lack of Assurance of Sterility; improperly crimped fliptop vials
December 3, 2014Medical DevicesFDA
Hospira Inc. recalls GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Prod
Hazard: Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via website sponsors by downloading the GemStar User/Service Manual featured on the sponsors' websites. The GemStar User/Service Manual should be removed from these w
December 3, 2014Medical DevicesFDA
Hospira Inc. recalls GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Prod
Hazard: Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via website sponsors by downloading the GemStar User/Service Manual featured on the sponsors' websites. The GemStar User/Service Manual should be removed from these w
December 3, 2014DrugsFDA
Hospira Inc. recalls Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
December 3, 2014DrugsFDA
Hospira Inc. recalls 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 N
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
December 3, 2014DrugsFDA
Hospira Inc. recalls 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045,
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
December 3, 2014DrugsFDA
Hospira Inc. recalls Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
December 3, 2014DrugsFDA
Hospira Inc. recalls Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
December 3, 2014DrugsFDA
Hospira Inc. recalls 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Fo
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
December 3, 2014DrugsFDA
Hospira Inc. recalls Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
December 3, 2014DrugsFDA
Hospira Inc. recalls 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Fo
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
December 3, 2014DrugsFDA
Hospira Inc. recalls 5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-79
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
December 3, 2014DrugsFDA
Hospira Inc. recalls Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
December 3, 2014DrugsFDA
Hospira Inc. recalls Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc.
Hazard: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
November 26, 2014DrugsFDA
Hospira Inc. recalls Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx o
Hazard: Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
November 5, 2014Medical DevicesFDA
Hospira Inc. recalls The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supp
Hazard: The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.
November 5, 2014Medical DevicesFDA
Hospira Inc. recalls The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supp
Hazard: The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.
October 29, 2014DrugsFDA
Hospira Inc. recalls Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01),
Hazard: Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
October 22, 2014DrugsFDA
Hospira Inc. recalls Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and
Hazard: Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
October 8, 2014DrugsFDA
Hospira Inc. recalls Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, I
Hazard: Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
October 1, 2014DrugsFDA
Hospira Inc. recalls Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock,
Hazard: Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
September 24, 2014DrugsFDA
Hospira Inc. recalls Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural An
Hazard: Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
August 27, 2014DrugsFDA
Hospira Inc. recalls Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl
Hazard: Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
August 27, 2014DrugsFDA
Hospira Inc. recalls DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lak
Hazard: Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
July 23, 2014DrugsFDA
Hospira Inc. recalls Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. H
Hazard: Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
July 16, 2014Medical DevicesFDA
Hospira Inc. recalls GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150.
Hazard: The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
July 16, 2014Medical DevicesFDA
Hospira Inc. recalls The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite
Hazard: Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (Version 13.40, 13.41, and 13.4.2) via Auto Programming when those dosing units are not properly established in the customized drug library. A dosing unit mismatch of "nanog/kg/min" or "milliUnits/min" on an unmatched medication will produce a
July 16, 2014DrugsFDA
Hospira Inc. recalls Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Si
Hazard: Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
July 16, 2014DrugsFDA
Hospira Inc. recalls Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/cart
Hazard: Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution