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 101 bottles of Briviact (brivaracetam) 50 mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 67 boxes of SYMPROIC (naldemedine) tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 141 bottles of Theophylline Extended-Release Tablets 400 mg due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 133 bottles of COREG CR 80 mg capsules due to intermittent temperature exposure 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 35 bottles of Haloperidol 20mg tablets due to intermittent exposure to 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 659 bottles of Namzaric capsules due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 13 bottles of LEVOXYL tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling Narcan (naloxone hydrochloride) nasal spray due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 284 bottles of Synjardy tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 244 bottles of Edarbyclor tablets due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 72 cartons of Estradiol Transdermal Systems due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 31 droptainers of Timolol Maleate Ophthalmic Solution 0.5% due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 235 bottles of Bisoprolol Fumarate and Hydrochlorothiazide tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 71 tubes of Miconazole 7 2% cream due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling Erythromycin Tablets 250mg due to intermittent temperature excursions during storage. The recall affects 135 cartons distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 592 bottles of Glyxambi tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 75 bottles of Benicar 40mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 122 bottles of Acetazolamide Tablets 125 mg due to intermittent temperature excursions during storage.
Cardinal Health is recalling 321 bottles of Fexofenadine Hydrochloride 180 mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 40 bottles of Nadolol 40 mg 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 523 bottles of Vitamin D3 Cholecalciferol 50,000 IU dietary supplements due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 4,065 cartons of Trelegy Ellipta inhalers due to intermittent exposure to temperature excursions during storage.