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 35 bottles of Calcium Acetate Capsules 667 mg due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 299 cartons of Belsomra (suvorexant) 20 mg tablets because of intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 882 bottles of VIMPAT (lacosamide) 200mg tablets due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 71 bottles of Metoprolol Tartrate and Hydrochlorothiazide tablets due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 223 bottles of Clindamycin Hydrochloride 150mg capsules due to intermittent 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 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 is recalling 504 cartons of Ivermectin Tablets USP 3 mg 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.
Cardinal Health is recalling 215 bottles of Steglatro (ertugliflozin) 15 mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 136 bottles of Auryxia (ferric citrate) 210 mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 31 tubes of Rectiv (nitroglycerin) ointment due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 2,907 bottles of Children's Loratadine Oral Solution due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 31 bottles of Benzoyl Peroxide 10% Acne Medication Wash due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 1,473 vials of Cathflo Activase (alteplase) 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 is recalling 1,776 boxes of Epinephrine auto-injectors due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 414 boxes of Epinephrine auto-injectors distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.
Cardinal Health is recalling 236 bottles of HySept Solution 0.25% Sodium Hypochlorite due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling Phenobarbital Tablets, USP 32.4 mg due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 12 bottles of COSOPT ophthalmic solution due to intermittent 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 Inc. is recalling Iron 100 with Vitamin C Tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling Prilosec (Omeprazole Magnesium) oral suspension packets due to intermittent 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.