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 667 Atrovent HFA inhalers due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 2,854 bottles of Loratadine 10mg tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.
Cardinal Health is recalling 940 cartons of Chantix (varenicline) tablets due to intermittent temperature excursions during storage. The affected products were distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 339 bottles of Ofloxacin 0.3% eye drops due to intermittent temperature excursions during storage.
Cardinal Health is recalling Benztropine Mesylate Tablets due to intermittent exposure to temperature excursions during storage. The affected products were distributed to Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 106 boxes of Fenofibrate capsules due to intermittent temperature excursions during storage.
Cardinal Health is recalling CATAPRES-TTS-2 adhesive patches due to intermittent exposure to temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling Valsartan 40 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 143 tubes of Hydrocortisone 1% cream due to intermittent temperature excursions during storage.
Cardinal Health is recalling 328 bottles of EDARBI tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 23 tubes of Hydrocortisone Ointment USP 1% due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 834 containers of Proctofoam HC aerosol due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
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 is recalling 80 bottles of Folivane-Plus capsules because they were intermittently exposed to temperature excursions during storage.
Cardinal Health is recalling 269 bottles of Synjardy XR tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling Trazodone Hydrochloride 50mg tablets due to intermittent exposure to 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 240 bottles of Lidocaine HCL Visc 2% 100ml due to intermittent temperature excursions during storage.
Cardinal Health is recalling 11 bottles of Enbrace HR prenatal vitamins due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 1,391 tubes of Collagenase Santyl Ointment due to intermittent temperature excursions during storage.
Cardinal Health is recalling Gemcitabine Injection 200mg/5.26ml vials due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling 178 tubes of Triamcinolone Acetonide Ointment, 0.025%, 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 Inc. is recalling 148 syringes of medroxyprogesterone acetate injectable suspension due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 286 prefilled syringes of medroxyprogesterone acetate due to intermittent temperature excursions during storage.