Fresenius Kabi Usa recalls
Fresenius Kabi Usa appears in 95 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 10…
FDA Drug · Class I · 2022-03-30 · Fresenius Kabi Usa
Reason: Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose. - Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 v…
FDA Drug · Class II · 2021-10-06 · Fresenius Kabi Usa
Reason: Defective container: Cracked vials leading to lack of sterility assurance - Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose V…
FDA Drug · Class II · 2021-07-14 · Fresenius Kabi Usa
Reason: Low out of specification results for epinephrine assay. - Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00)
FDA Drug · Class I · 2021-02-03 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter - found in reserve sample vials at the firm. - Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zuri…
FDA Drug · Class II · 2021-01-06 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter - found in reserve sample vials at the firm. - Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-4…
FDA Drug · Class II · 2020-12-30 · Fresenius Kabi Usa
Reason: Subpotent Drug: Low out-of-specification assay results for the epinephrine component. - Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lak…
FDA Drug · Class I · 2020-12-16 · Fresenius Kabi Usa
Reason: Cross Contamination with other products: trace amounts of lidocaine - DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius…
FDA Drug · Class III · 2020-12-02 · Fresenius Kabi Usa
Reason: Cross Contamination with Other Products: trace amounts of octreotide found during testing - Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL…
FDA Drug · Class I · 2020-09-02 · Fresenius Kabi Usa
Reason: Cross Contamination with other products: trace amounts of lidocaine - Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047
FDA Drug · Class III · 2020-07-22 · Fresenius Kabi Usa
Reason: Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / via… - Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00)
FDA Drug · Class I · 2020-06-17 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter - found in reserve sample vials at the firm. - Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Sing…
FDA Drug · Class II · 2020-06-17 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter - found in reserve sample vials at the firm. - Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 600…
FDA Drug · Class I · 2019-07-24 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter; glass particulates - Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
FDA Drug · Class III · 2019-06-19 · Fresenius Kabi Usa
Reason: Failed Impurities/Degradation Specifications. - SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL…
FDA Drug · Class I · 2018-12-12 · Fresenius Kabi Usa
Reason: Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber… - SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL…
FDA Drug · Class I · 2018-12-12 · Fresenius Kabi Usa
Reason: Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber… - Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
FDA Drug · Class III · 2018-02-07 · Fresenius Kabi Usa
Reason: Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station. - Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius…
FDA Drug · Class I · 2018-01-10 · Fresenius Kabi Usa
Reason: Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL - Fluphenazine Decanoate Injection, USP
FDA Drug · Class III · 2017-04-12 · Fresenius Kabi Usa
Reason: Subpotent Drug - MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173…
FDA Drug · Class II · 2017-02-08 · Fresenius Kabi Usa
Reason: Failed Impurities/Degradation Specifications - Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 6004…
FDA Drug · Class II · 2016-06-22 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter: Glass particulate found in sterile injectable product - OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schau…
FDA Drug · Class II · 2016-06-01 · Fresenius Kabi Usa
Reason: Failed Impuities/Degradation Specifications - OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schau…
FDA Drug · Class II · 2016-06-01 · Fresenius Kabi Usa
Reason: Failed Impuities/Degradation Specifications - Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only
FDA Drug · Class III · 2016-04-20 · Fresenius Kabi Usa
Reason: Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result. - Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Ka…
FDA Drug · Class II · 2016-04-20 · Fresenius Kabi Usa
Reason: Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9%… - Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL
FDA Drug · Class III · 2015-08-19 · Fresenius Kabi Usa
Reason: Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016) - Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 600…
FDA Drug · Class II · 2015-07-22 · Fresenius Kabi Usa
Reason: Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation - KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose
FDA Drug · Class II · 2015-06-10 · Fresenius Kabi Usa
Reason: Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids - HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi U…
FDA Device · Class II · 2015-02-04 · Fresenius Kabi Usa
Reason: The lot failed pH specification. - CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only
FDA Drug · Class II · 2014-12-17 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. - GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg,…
FDA Drug · Class II · 2014-12-17 · Fresenius Kabi Usa
Reason: Defective Container: Vials may be missing stoppers. - ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only
FDA Drug · Class II · 2014-12-17 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. - MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only
FDA Drug · Class II · 2014-12-17 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. - HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
FDA Drug · Class III · 2014-11-19 · Fresenius Kabi Usa
Reason: Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result. - PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-…
FDA Drug · Class II · 2014-08-27 · Fresenius Kabi Usa
Reason: CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection. - Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufact…
FDA Drug · Class II · 2014-07-16 · Fresenius Kabi Usa
Reason: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. - Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manuf…
FDA Drug · Class II · 2014-07-16 · Fresenius Kabi Usa
Reason: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. - Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540…
FDA Drug · Class II · 2014-03-12 · Fresenius Kabi Usa
Reason: Subpotent; 18 month time point - Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only
FDA Drug · Class II · 2014-01-29 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container. - FOLIC ACID INJECTION, USP
FDA Drug · Class III · 2013-12-25 · Fresenius Kabi Usa
Reason: Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point - PACLITAXEL INJECTION, USP (semisynthetic)
FDA Drug · Class III · 2013-12-04 · Fresenius Kabi Usa
Reason: Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections. - Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmace…
FDA Drug · Class I · 2013-09-04 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review. - Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Phar…
FDA Drug · Class II · 2013-07-24 · Fresenius Kabi Usa
Reason: Subpotent Drug; 15-month stability test station - Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 6017…
FDA Drug · Class III · 2013-07-17 · Fresenius Kabi Usa
Reason: Failed Impurities/Degradation Specification - Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuti…
FDA Drug · Class II · 2013-07-17 · Fresenius Kabi Usa
Reason: Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials