Recall archive
61 recalls · page 2 of 3
Reported Oct 12, 2022
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as…
FDA (openFDA device enforcement)
Reported Mar 30, 2022
Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon,…
FDA (openFDA drug enforcement)
Reported Jul 14, 2021
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA LLC
Matched: Brand · Product details — Low out of specification results for epinephrine assay.
FDA (openFDA drug enforcement)
Reported Feb 3, 2021
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Presence of Particulate Matter - found in reserve sample vials at the firm.
FDA (openFDA drug enforcement)
Reported Jan 6, 2021
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Presence of Particulate Matter - found in reserve sample vials at the firm.
FDA (openFDA drug enforcement)
Reported Dec 30, 2020
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
FDA (openFDA drug enforcement)
Reported Dec 16, 2020
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Cross Contamination with other products: trace amounts of lidocaine
FDA (openFDA drug enforcement)
Reported Dec 2, 2020
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Cross Contamination with Other Products: trace amounts of octreotide found during testing
FDA (openFDA drug enforcement)
Reported Sep 2, 2020
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Cross Contamination with other products: trace amounts of lidocaine
FDA (openFDA drug enforcement)
Reported Jul 22, 2020
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047;…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium…
FDA (openFDA drug enforcement)
Reported Jun 17, 2020
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Presence of Particulate Matter - found in reserve sample vials at the firm.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jul 24, 2019
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Presence of Particulate Matter; glass particulates
FDA (openFDA drug enforcement)
Reported Jun 19, 2019
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications.
FDA (openFDA drug enforcement)
Reported Dec 12, 2018
SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Reason for recall — Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Feb 7, 2018
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
FDA (openFDA drug enforcement)
Reported Jan 10, 2018
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg /…
FDA (openFDA drug enforcement)
Reported Apr 19, 2017
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical Surgical
Matched: Product details — Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the…
FDA (openFDA drug enforcement)
Reported Apr 12, 2017
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
Matched: Brand — Subpotent Drug
FDA (openFDA drug enforcement)
Reported Feb 8, 2017
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand — Failed Impurities/Degradation Specifications
FDA (openFDA drug enforcement)
Reported Jun 22, 2016
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Presence of Particulate Matter: Glass particulate found in sterile injectable product
FDA (openFDA drug enforcement)
Reported Jun 1, 2016
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Failed Impuities/Degradation Specifications
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 20, 2016
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 19, 2015
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
FDA (openFDA drug enforcement)
Reported Jul 22, 2015
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
FDA (openFDA drug enforcement)
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