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High RiskFDA
Cardinal Health Inc.
LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01
Oral Drugs·13 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
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...
Inhaled / Nasal Drugs·38 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
Injectable Drugs·3 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC:...
Injectable Drugs·620 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
Ophthalmic Drugs·152 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
Inhaled / Nasal Drugs·667 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS
Drugs·64 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed ...
Oral Drugs·940 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmace...
Drugs·72 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Bl...
Oral Drugs·299 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, ...
Oral Drugs·255 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured fo...
Injectable Drugs·414 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS
Oral Drugs·1,371 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35
Oral Drugs·882 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan ...
Oral Drugs·453 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise ...
Topical Drugs·189 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx onl...
Drugs·26,895 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901,...
Oral Drugs·223 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals...
Oral Drugs·4 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683
Oral Drugs·133 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distrib...
Oral Drugs·659 affected·Mar 15, 2021
High RiskFDA
Medline Industries Inc
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute spec...
Medical Devices·24 affected·Mar 15, 2021
High RiskFDA
Medtronic Minimed
MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 67...
Diabetes Devices·1,266 affected·Mar 15, 2021
High RiskFDA
Lehi Valley Trading Co, Inc
Buc-ee's Butter Toffee Almonds, 12 oz., packaged in clear zip top bag with stickered label, UPC: 0 9524842002 4, Manufactured and package...
Dairy·96 affected·Mar 12, 2021
High RiskFDA
Mindo Chocolate Makers Llc
Mindo COFFEE TOFFEE CHOCOLATE BAR, 75 gram / 2.65oz UPC code 805993900527. Also sold in 12 count and 6 count cartons
Snacks & Candy·2,187 affected·Mar 11, 2021
High RiskFDA
Ferring Pharmaceuticals Inc
ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demon...
Injectable Drugs·1,569 affected·Mar 11, 2021
High RiskFDA
Ferring Pharmaceuticals Inc
ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 ...
Injectable Drugs·301 affected·Mar 11, 2021
High RiskFDA
Breckenridge Pharmaceutical, Inc
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, C...
Oral Drugs·3,146 affected·Mar 11, 2021
High RiskFDA
Sagent Pharmaceuticals Inc
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intrave...
Injectable Drugs·3,716 affected·Mar 11, 2021
High RiskFDA
Liebel-flarsheim Company Llc
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Medical Devices·17 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
Medical Devices·441,500 affected·Mar 11, 2021
High RiskFDA
Stryker Spine
Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (5802201...
Medical Devices·169 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
Medical Devices·18,000 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
Medical Devices·10,000 affected·Mar 11, 2021
High RiskFDA
Tippins
Tippin's Country Gravy, Net Wt 16 OZ, Keep Refrigerated, Tippin's Gourmet Pies LLC, Kansas City, KS UPC 6 80816 12023 1 packaged in plast...
Food·46 affected·Mar 10, 2021
High RiskFDA
China Gel Inc
CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 ...
Topical Drugs·40,289 affected·Mar 10, 2021
High RiskFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net C...
Drugs·8,609,863 affected·Mar 10, 2021
High RiskFDA
China Gel Inc
CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g)...
Topical Drugs·92,472 affected·Mar 10, 2021
High RiskFDA
China Gel Inc
aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 763...
Topical Drugs·3,458 affected·Mar 10, 2021
High RiskFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5)...
Drugs·43,164 affected·Mar 10, 2021
High RiskFDA
Remel Inc
Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in ...
Medical Devices·19 affected·Mar 10, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull...
Medical Devices·12 affected·Mar 10, 2021
High RiskFDA
Icu Medical Inc
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045...
Drugs·425,628 affected·Mar 9, 2021
High RiskFDA
Quirch Foods
Yellowfin Tuna portions Frozen IVP-CO Treated, Net WT 20 LBS, Size 1 LB.
Seafood·55 affected·Mar 8, 2021
High RiskFDA
Akorn, Inc.
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech...
Oral Drugs·8,183 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·1,000 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing an...
Cardiac Devices·3,664 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia paci...
Cardiac Devices·702 affected·Mar 8, 2021