Fresenius Kabi USA, LLC

FDA Drug Class I Ongoing

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

November 6, 2025 Fresenius Kabi USA, LLC 2,199,850 vials units

FDA Drug Class II Terminated

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in

November 22, 2022 Fresenius Kabi USA, LLC 40,025 vials units

FDA Drug Class II Terminated

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged

November 22, 2022 Fresenius Kabi USA, LLC 40,375 vials units

FDA Drug Class II Terminated

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged

November 22, 2022 Fresenius Kabi USA, LLC 31,600 vials units

FDA Drug Class I Terminated

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: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Frese

March 4, 2022 Fresenius Kabi USA, LLC 118,040 vials units

FDA Drug Class II Terminated

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 vials per tray packaged 18 trays per shipper

September 17, 2021 Fresenius Kabi USA, LLC 963000 vials units

FDA Drug Class II Terminated

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 Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lak

June 25, 2021 Fresenius Kabi USA, LLC 234,800 vials units

FDA Drug Class I Terminated

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Freseniu

December 23, 2020 Fresenius Kabi USA, LLC 945,425 vials units

FDA Drug Class II Terminated

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 Zurich, IL 60047, NDC 63323-162-02

December 17, 2020 Fresenius Kabi USA, LLC 490,633 vials units

FDA Drug Class II Terminated

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 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-

December 10, 2020 Fresenius Kabi USA, LLC 4411 trays units

FDA Drug Class III Terminated

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 Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05

November 17, 2020 Fresenius Kabi USA, LLC 16,986 vials units

FDA Drug Class I Terminated

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05

November 17, 2020 Fresenius Kabi USA, LLC 13,525 bottles units

FDA Drug Class I Terminated

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL

July 22, 2020 Fresenius Kabi USA, LLC 25,100 bottles units

FDA Drug Class III Terminated

Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10

July 13, 2020 Fresenius Kabi USA, LLC 63,067 vials units

FDA Drug Class II Terminated

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 Single Dose Vials per tray (NDC 63323-162-02); For IM use only, N

April 20, 2020 Fresenius Kabi USA, LLC 3,497,575 vials units

FDA Drug Class I Terminated

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Freseniu

April 20, 2020 Fresenius Kabi USA, LLC 5,314,400 vials units

FDA Drug Class I Terminated

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 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-6

June 28, 2019 Fresenius Kabi USA, LLC 14,016 vials units

FDA Drug Class III Terminated

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

May 22, 2019 Fresenius Kabi USA, LLC 11,981 units units

FDA Drug Class I Terminated

SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610

November 15, 2018 Fresenius Kabi USA, LLC 23,745,300 10 mL vials units

FDA Drug Class I Terminated

SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620

November 15, 2018 Fresenius Kabi USA, LLC 1,312,350 20 mL vials units

FDA Drug Class III Terminated

Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10

January 16, 2018 Fresenius Kabi USA, LLC 35,620 vials units

FDA Drug Class I Terminated

Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20

October 27, 2017 Fresenius Kabi USA, LLC 203136 syringes units

FDA Drug Class III Terminated

Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05

March 16, 2017 Fresenius Kabi USA, LLC 118,224 vials units

FDA Drug Class II Terminated

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 --- NDC 63323-412-05

December 16, 2016 Fresenius Kabi USA, LLC 47, 020 vials units

FDA Drug Class II Terminated

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.

May 4, 2016 Fresenius Kabi USA, LLC 355,150 vials units

FDA Drug Class II Terminated

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04

May 4, 2016 Fresenius Kabi USA, LLC 40,280 vials units

FDA Drug Class II Terminated

Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37

April 25, 2016 Fresenius Kabi USA, LLC 69225 units units

FDA Drug Class III Terminated

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

April 7, 2016 Fresenius Kabi USA, LLC 48,210 units units

FDA Drug Class II Terminated

Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10

April 5, 2016 Fresenius Kabi USA, LLC 94,560 vials units

FDA Drug Class III Terminated

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3

July 28, 2015 Fresenius Kabi USA, LLC 93,000 vials units

FDA Drug Class II Terminated

Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park,

June 4, 2015 Fresenius Kabi USA, LLC 7,593 vials units

FDA Drug Class II Terminated

KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540

April 28, 2015 Fresenius Kabi USA, LLC 5,488 Bags units

FDA Drug Class II Terminated

GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20

November 12, 2014 Fresenius Kabi USA, LLC 92,125 vials units

FDA Drug Class II Terminated

PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01

August 13, 2014 Fresenius Kabi USA, LLC 56,060 vials units

FDA Drug Class II Terminated

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047

May 2, 2014 Fresenius Kabi USA, LLC 728,880 vials units

FDA Drug Class II Terminated

Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047,

May 2, 2014 Fresenius Kabi USA, LLC 2,070,500 vials units

FDA Drug Class III Terminated

HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01

April 14, 2014 Fresenius Kabi USA, LLC 216,517 vials units

FDA Drug Class II Terminated

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 63323-540-11, 25 vials in tray, each boxed vial individually labeled a

January 22, 2014 Fresenius Kabi USA, LLC 161,650 vials units

FDA Drug Class III Terminated

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 60173 NDC 63323-184-11

December 6, 2013 Fresenius Kabi USA, LLC 215,340 vials units

FDA Drug Class III Terminated

PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India

November 8, 2013 Fresenius Kabi USA, LLC 71,129 vials units

FDA Drug Class II Terminated

Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-

October 31, 2013 Fresenius Kabi USA, LLC 121,456 vials units

FDA Drug Class II Terminated

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 Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Man

July 1, 2013 Fresenius Kabi USA, LLC 65110 vials units

FDA Drug Class II Terminated

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 Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.

June 24, 2013 Fresenius Kabi USA, LLC 221,600 vials units

FDA Drug Class I Terminated

Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50

May 25, 2013 Fresenius Kabi USA, LLC 15,625 vials units

FDA Drug Class III Terminated

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 60173, NDC 63323-184-11

May 21, 2013 Fresenius Kabi USA, LLC 80,480 vials units

FDA Drug Class II Terminated

ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02

September 27, 2012 Fresenius Kabi USA, LLC 184,550 Vials units

FDA Drug Class II Terminated

MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.

September 27, 2012 Fresenius Kabi USA, LLC 101,200 Vials units

FDA Drug Class II Terminated

CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.

September 27, 2012 Fresenius Kabi USA, LLC 240,550 Vials units