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 23 tubes of Hydrocortisone Ointment USP 1% due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 163 bottles of Polyethylene Glycol 3350 Powder for Solution due to intermittent exposure to 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 3,688 bottles of Restasis 0.05% eye drops due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 148 syringes of medroxyprogesterone acetate injectable suspension due to intermittent exposure to temperature excursions during storage.
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 Inc. is recalling 513 bottles of Verapamil Hydrochloride Extended-Release Tablets 120 mg due to intermittent 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 Inc. is recalling 325 cartons of Travoprost Ophthalmic Solution due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 240 bottles of Lidocaine HCL Visc 2% 100ml 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 is recalling 215 bottles of Steglatro (ertugliflozin) 15 mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling Benzoyl Peroxide 2.5% Acne Treatment Gel due to intermittent temperature excursions 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 341 vials of Methotrexate Injection due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling Hydrocortisone Acetate 30mg suppositories due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling NOHIST DM antihistamine and decongestant liquid due to intermittent 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 Inc. is recalling 1,669 bottles of Creon (pancrelipase) capsules due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 47 cartons of Belbuca (buprenorphine hydrochloride) buccal film due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 205 bottles of Vitamin D3 Cholecalciferol 50,000 IU dietary supplements due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 664 bottles of XIGDUO tablets because of intermittent temperature exposure during storage. The affected products were distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 1,189 cartons of Ozempic (oral semaglutide) tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 30 bottles of Banzel (rufinamide) 200 mg tablets due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 38 bottles of Butorphanol Tartrate Nasal Solution due to intermittent temperature excursions during storage.