FDA (Drugs) recall action 87512
The FDA (Drugs) publishes a recall like this one as 198 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 198 pages.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Cardinal Health Inc. is recalling 345 cartons of Ibuprofen Oral Suspension USP 100mg/5ml due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling Pregabalin 300mg capsules due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 47 bottles of NAT B VIT D3 2000U tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 1,935 bottles of Ondansetron HCL 4mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 406 vials of Tubersol Tuberculin PPD due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling Vitamin D3 50mcg softgels due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 131 bottles of Lamotrigine Extended-Release Tablets 250 mg due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 189 tubes of Rugby Benzoyl Peroxide Gel 5% due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling Eletriptan Hydrobromide 20 mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 64 boxes of Enoxaparin Dofium Injection 150mg/1ml syringes due to intermittent temperature excursions during storage.
Cardinal Health is recalling 269 bottles of Synjardy XR tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling Promethazine Plain Oral Solution due to intermittent temperature excursions during storage.
Cardinal Health is recalling 15,885 bottles of Oseltamivir Phosphate for Oral Suspension due to intermittent temperature excursions during storage.
Cardinal Health is recalling 759 bottles of Vraylar (cariprazine) capsules due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling Bromfenac Ophthalmic Solution 0.09% due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 15 bottles of Nitrofurantoin Macrocrystals Capsules 25 mg due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 453 bottles of Livalo (pitavastatin calcium) 2 mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 88 bottles of Banophen Diphenhydramine HCl 25 mg capsules due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 112 bottles of Levothyroxine Sodium Tablets due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 424 bottles of Atropine Sulfate Ophthalmic Solution 1% due to intermittent temperature excursions during storage.
Cardinal Health is recalling 2,854 bottles of Loratadine 10mg tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.
Cardinal Health is recalling 1,473 vials of Cathflo Activase (alteplase) due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 1,040 cartons of Chantix (varenicline tartrate) tablets due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 796 bottles of VIMPAT (lacosamide) 100 mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 378 bottles of XIGDUO tablets due to intermittent exposure to temperature excursions during storage.