Cardinal Health Inc.

FDA Drug Class II Ongoing

Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer packa

August 5, 2025 Cardinal Health Inc. 10 bags units

FDA Drug Class II Ongoing

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

July 30, 2025 Cardinal Health Inc. 6 units units

FDA Drug Class II Ongoing

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

July 30, 2025 Cardinal Health Inc. 4 units units

FDA Drug Class II Ongoing

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

July 30, 2025 Cardinal Health Inc. 3 units units

FDA Drug Class II Ongoing

Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by:

April 9, 2025 Cardinal Health Inc. 48 Cartons units

FDA Drug Class I Ongoing

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1

October 31, 2023 Cardinal Health Inc. 119,871 bottles units

FDA Drug Class I Ongoing

LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1

October 31, 2023 Cardinal Health Inc. 8,784 bottles units

FDA Drug Class I Ongoing

LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1

October 31, 2023 Cardinal Health Inc. 21,802 bottles units

FDA Drug Class I Ongoing

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70

October 31, 2023 Cardinal Health Inc. 28477 cartons units

FDA Drug Class I Ongoing

LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Oh

October 31, 2023 Cardinal Health Inc. 11629 units units

FDA Drug Class I Ongoing

LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 7

October 31, 2023 Cardinal Health Inc. 11,782 bottles units

FDA Drug Class II Completed

Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80

April 5, 2022 Cardinal Health Inc. 1 box units

FDA Drug Class I Completed

Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59

April 5, 2022 Cardinal Health Inc. 1 box units

FDA Drug Class II Completed

Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80

April 5, 2022 Cardinal Health Inc. 1 box units

FDA Drug Class II Terminated

Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9

March 15, 2021 Cardinal Health Inc. 38 bottles units

FDA Drug Class II Terminated

GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL

March 15, 2021 Cardinal Health Inc. 3 CARTON units

FDA Drug Class II Terminated

Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336

March 15, 2021 Cardinal Health Inc. 504 cartons units

FDA Drug Class II Terminated

ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 135 CARTON units

FDA Drug Class II Terminated

NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01

March 15, 2021 Cardinal Health Inc. 41 bottles units

FDA Drug Class II Terminated

PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 3 bottles units

FDA Drug Class II Terminated

Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo Allegan, MI 49010

March 15, 2021 Cardinal Health Inc. 163 bottles units

FDA Drug Class II Terminated

Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827

March 15, 2021 Cardinal Health Inc. 523 bottles units

FDA Drug Class II Terminated

Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07

March 15, 2021 Cardinal Health Inc. 160 bottles units

FDA Drug Class II Terminated

HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076

March 15, 2021 Cardinal Health Inc. 236 bottles units

FDA Drug Class II Terminated

TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10

March 15, 2021 Cardinal Health Inc. 86 BOTTLE units

FDA Drug Class II Terminated

LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS

March 15, 2021 Cardinal Health Inc. 2854 bottles units

FDA Drug Class II Terminated

Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328

March 15, 2021 Cardinal Health Inc. 328 bottles units

FDA Drug Class II Terminated

xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by

March 15, 2021 Cardinal Health Inc. 664 bottles units

FDA Drug Class II Terminated

Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612

March 15, 2021 Cardinal Health Inc. 96 cartons units

FDA Drug Class II Terminated

Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA

March 15, 2021 Cardinal Health Inc. 422 bottles units

FDA Drug Class II Terminated

NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS

March 15, 2021 Cardinal Health Inc. 4 bottles units

FDA Drug Class II Terminated

NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)

March 15, 2021 Cardinal Health Inc. 1240 CARTON units

FDA Drug Class II Terminated

EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 7 CARTON units

FDA Drug Class II Terminated

Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110

March 15, 2021 Cardinal Health Inc. 1 bottle units

FDA Drug Class II Terminated

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey

March 15, 2021 Cardinal Health Inc. 834 aerosol containers units

FDA Drug Class II Terminated

Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612

March 15, 2021 Cardinal Health Inc. 72 tubes units

FDA Drug Class II Terminated

MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM

March 15, 2021 Cardinal Health Inc. 71 tubes units

FDA Drug Class II Terminated

Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36

March 15, 2021 Cardinal Health Inc. 178 tubes units

FDA Drug Class II Terminated

PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16

March 15, 2021 Cardinal Health Inc. 49 CARTON units

FDA Drug Class II Terminated

Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline R

March 15, 2021 Cardinal Health Inc. 2264 bottles units

FDA Drug Class II Terminated

medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02

March 15, 2021 Cardinal Health Inc. 148 syringes units

FDA Drug Class II Terminated

CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES

March 15, 2021 Cardinal Health Inc. 17 patches units

FDA Drug Class II Terminated

ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 1935 bottles units

FDA Drug Class II Terminated

UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 964 bottles units

FDA Drug Class II Terminated

TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

March 15, 2021 Cardinal Health Inc. 4065 CARTON units

FDA Drug Class II Terminated

Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451,

March 15, 2021 Cardinal Health Inc. 205 cartons units

FDA Drug Class II Terminated

Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC. Peapack, NJ 07977

March 15, 2021 Cardinal Health Inc. 286 syringes units

FDA Drug Class II Terminated

Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520

March 15, 2021 Cardinal Health Inc. 20 CARTONS units

FDA Drug Class II Terminated

PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES

March 15, 2021 Cardinal Health Inc. 6 CONTAINERS units

FDA Drug Class II Terminated

LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 12 bottles units