June 2, 2021DrugsFDA
Cardinal Health Inc. recalls NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Labor
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urba
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Toky
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuti
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Ea
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. E
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceutica
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Sup
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlant
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufac
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.