Recall archive
117 recalls · page 1 of 5
Reported May 22, 2024
Hospira Inc. recalls Hospira Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units due to Device &…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Hospira Inc.
Matched: Brand · Product · Product details — Device & Drug Safety – Potential Packaging Defect
FDA (recalls & safety alerts)
Reported Nov 15, 2023
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Pfizer Inc.
Matched: Product details — Presence of Particulate Matter: identified as glass.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 13, 2018
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc., Lake Forest
Matched: Brand · Product details — Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
FDA (openFDA drug enforcement)
Reported Mar 14, 2018
Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc. A Pfizer Company
Matched: Brand · Product · Product details — Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
FDA (openFDA drug enforcement)
Reported Jul 26, 2017
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hospira Inc., A Pfizer Company
Matched: Brand · Product details — Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
FDA (openFDA drug enforcement)
Reported Jun 21, 2017
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc., A Pfizer Company
Matched: Brand · Product · Product details — GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
FDA (openFDA drug enforcement)
Reported May 31, 2017
Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: human hair found within an internal sample syringe.
FDA (openFDA drug enforcement)
Reported Apr 12, 2017
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc., A Pfizer Company
Matched: Brand · Product details — 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…
FDA (openFDA drug enforcement)
Reported Apr 5, 2017
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc., A Pfizer Company
Matched: Brand — Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3…
FDA (openFDA device enforcement)
Reported Mar 1, 2017
METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc., A Pfizer Company
Matched: Brand · Product · Product details — Lack of Sterility Assurance: customer report of leaking bag
FDA (openFDA drug enforcement)
Reported Jan 18, 2017
Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Reason for recall — Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above…
FDA (openFDA device enforcement)
Reported Dec 28, 2016
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc., A Pfizer Company
Matched: Brand · Product details — Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
FDA (openFDA drug enforcement)
Reported Dec 14, 2016
5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hospira Inc.
Matched: Brand · Product details — Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
FDA (openFDA drug enforcement)
Reported Nov 30, 2016
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
FDA (openFDA drug enforcement)
Reported Nov 16, 2016
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 9, 2016
Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Reason for recall — B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine…
FDA (openFDA device enforcement)
Reported Nov 9, 2016
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Reason for recall — Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 2, 2016
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand — Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 19, 2016
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc., A Pfizer Company
Matched: Brand · Product · Product details — Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Sep 28, 2016
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2016
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc., A Pfizer Company
Matched: Brand · Product · Product details · Reason for recall — Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs…
FDA (openFDA device enforcement)
Reported Sep 21, 2016
DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Discoloration: Firm received complaints of product discoloration and particulates.
FDA (openFDA drug enforcement)
Reported Sep 14, 2016
Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand — The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 24, 2016
Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List Numbers…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details · Reason for recall — Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner…
1 more product in this recall
FDA (openFDA device enforcement)
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