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 31 tubes of Rectiv (nitroglycerin) ointment due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 2,611 units of Spiriva HandiHaler inhalers due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling Niacin 250mg tablets due to intermittent temperature excursions during storage. The recall affects 4 bottles distributed in Florida, Georgia, and South Carolina.
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 78 bottles of Siladryl 12.5/5ml liquid because of intermittent temperature excursions during storage.
Cardinal Health is recalling 848 bottles of Chantix (varenicline tartrate) tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling Leucovorin 15mg tablets due to intermittent temperature excursions during storage. The affected products were distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 147 units of Pedia-Lax 66ml enemas due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 490 bottles of Trokendi XR (topiramate) 100 mg capsules due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 32 bottles of bupropion hydrochloride tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 205 cartons of Intrarosa Prasterone Vaginal Inserts due to intermittent temperature excursions during storage.
Cardinal Health is recalling 463 boxes of Lotemax eye gel distributed in Florida, Georgia, and South Carolina 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 91 bottles of Penicillin V Potassium oral solution due to intermittent temperature excursions during storage.
Cardinal Health is recalling Prilosec (Omeprazole Magnesium) oral suspension packets due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 35 bags of Levofloxacin Injection due to intermittent temperature excursions during storage.
Cardinal Health is recalling Corgard (nadolol) 40 mg tablets 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 Benzefoam Emollient Foam due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 534 syringes of Invega Sustenna 156mg/1ml 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 12 bottles of COSOPT ophthalmic solution due to intermittent temperature excursions during storage.
Cardinal Health is recalling Vitamin D3 50mcg tablets due to intermittent exposure to temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
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 934 boxes of Polyethylene Glycol 3350 Powder for Solution due to intermittent temperature excursions during storage.