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 NURTEC ODT (rimegepant) tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 16 bottles of Phentermine HCL 30mg capsules due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 249 cartons of Buprenorphine and Naloxone Sublingual Film 4mg/1mg due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 57 bottles of Desvenlafaxine Extended-Release Tablets 25 mg due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 378 bottles of XIGDUO tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling Ezetimibe and Simvastatin tablets due to intermittent exposure to 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 934 boxes of Polyethylene Glycol 3350 Powder for Solution 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 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 is recalling Rugby Benzoyl Peroxide Wash 5% due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling NOHIST DM antihistamine and decongestant liquid due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 52 bottles of Darifenacin Extended-release Tablets 7.5 mg due to intermittent temperature excursions during storage.
Cardinal Health is recalling 297 units of Advair HFA inhalers due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 54 bottles of FaBB Vitamin B6, Folic Acid, and Vitamin B12 dietary supplements due to intermittent temperature excursions during storage.
Cardinal Health is recalling 1,529 bottles of Linzess (linaclotide) capsules due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 620 EpiPen auto-injectors distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.
Cardinal Health Inc. is recalling 318 droptainers of Dexamethasone Sodium Phosphate 0.1% eye drops due to temperature excursions during storage.
Cardinal Health Inc. is recalling 86 bottles of Tramadol Hydrochloride 100mg tablets 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 Bromfenac Ophthalmic Solution 0.09% due to intermittent exposure to 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 72 cartons of Estradiol Transdermal Systems due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling Cefazolin for Injection due to intermittent exposure to temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 38 bottles of Butorphanol Tartrate Nasal Solution due to intermittent temperature excursions during storage.