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 49 bottles of LYRICA (pregabalin) 200mg capsules due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 15 bottles of a cough syrup due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 1,669 bottles of Creon (pancrelipase) capsules due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling MURO-128 2% eye drops due to intermittent temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling Pantoprazole Sodium Delayed-Release Tablets due to intermittent 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 1,371 bottles of Cetirizine Hydrochloride Tablets, 10 mg, due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 123 bottles of Synthroid (levothyroxine sodium) tablets distributed in Florida, Georgia, and South Carolina due to intermittent 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 Inc. is recalling 2,611 units of Spiriva HandiHaler inhalers due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 701 cartons of Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment due to intermittent 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 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 Inc. is recalling 373 bottles of Amoxicillin 500mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 41 bottles of prenatal tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 47 droptainers of Tobramycin/Dexamethasone eye drops due to intermittent temperature excursions during storage.
Cardinal Health is recalling 255 bottles of Nuedexta capsules due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling Pravachol 40mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 119 cartons of Belsomra (suvorexant) 10 mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 55 boxes of Zolpidem Tartrate Sublingual Tablets 3.5 mg 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 Inc. is recalling 31 cartons of Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 32 bottles of Integra 325/40/3mg due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 40 bottles of Nadolol 40 mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 353 Arnuity Ellipta inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.