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 32 bottles of Integra 325/40/3mg due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling Ilevro (nepafenac ophthalmic suspension) 0.3% due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 60 cartons of TRI-LO-MARZIA oral contraceptives distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 373 bottles of Amoxicillin 500mg tablets due to intermittent exposure to 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 is recalling 1,391 tubes of Collagenase Santyl Ointment due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 143 tubes of Hydrocortisone 1% cream due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 905 units of Budesonide and Formoterol Fumarate Dihydrate inhalers due to intermittent temperature exposure during storage.
Cardinal Health Inc. is recalling 237 units of Flovent Diskus 100mcg inhalers due to intermittent temperature excursions during storage.
Cardinal Health is recalling 210 cartons of Orilissa (elagolix) tablets 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 is recalling 1,529 bottles of Linzess (linaclotide) capsules due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 249 cartons of Buprenorphine and Naloxone Sublingual Film 4mg/1mg due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling Rugby Benzoyl Peroxide Wash 5% due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 286 prefilled syringes of medroxyprogesterone acetate due to intermittent temperature excursions during storage.
Cardinal Health is recalling 35 bottles of Calcium Acetate Capsules 667 mg 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 39 bottles of Risperidone 1mg/mL solution due to intermittent 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 Inc. is recalling 271 bottles of Amantadine Hydrochloride 100 mg tablets 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 Inc. is recalling 180 bottles of Podofilox Topical Solution 0.5% due to intermittent exposure to temperature excursions during storage.
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 Inc. is recalling 1,278 bottles of Brilinta (ticagrelor) 60 mg tablets due to intermittent exposure to temperature excursions during storage.