June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Hu
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pa
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceutical
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceutica
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-68
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morg
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured fo
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morg
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; 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 Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a sub
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Bliste
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Bliste
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods P
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls TRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; NDC/UPC 68180-837-73; RX; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.