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 is recalling 40 bags of Ciprofloxacin IV solution due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 362 bottles of Norvir (ritonavir) 100 mg tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 101 bottles of Briviact (brivaracetam) 50 mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 828 Levalbuterol tartrate HFA inhalers distributed in Florida, Georgia, and South Carolina due to intermittent 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 is recalling Narcan (naloxone hydrochloride) nasal spray due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 751 bottles of Synjardy XR tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.
Cardinal Health Inc. is recalling 237 units of Flovent Diskus 100mcg inhalers due to intermittent temperature excursions during storage.
Cardinal Health is recalling 55 bottles of Therapeutic M 130 tablets due to intermittent 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 is recalling 10 bottles of Enalapril Maleate Tablets 2.5 mg due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 576 bottles of Meloxicam 7.5 mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 30 bottles of Banzel (rufinamide) 200 mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 160 bottles of Colcrys tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 141 bottles of Theophylline Extended-Release Tablets 400 mg due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 23 bottles of Balziva (norethindrone and ethinyl estradiol) due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 91 bottles of Penicillin V Potassium oral solution due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 905 units of Budesonide and Formoterol Fumarate Dihydrate inhalers due to intermittent temperature exposure 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 is recalling Ciprodex eye drops due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling Ilevro (nepafenac ophthalmic suspension) 0.3% due to intermittent exposure to 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 Inc. is recalling 180 bottles of Podofilox Topical Solution 0.5% due to intermittent exposure to temperature excursions during storage.