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 1,935 bottles of Ondansetron HCL 4mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU softgels 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 964 bottles of Ubrelvy 100mg tablets due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 16 tubes of Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser due to intermittent temperature excursions during storage.
Cardinal Health is recalling 463 boxes of Lotemax eye gel distributed in Florida, Georgia, and South Carolina 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 is recalling 534 syringes of Invega Sustenna 156mg/1ml due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 848 bottles of Chantix (varenicline tartrate) tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 244 bottles of Edarbyclor tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 15,885 bottles of Oseltamivir Phosphate for Oral Suspension due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 73 cartons of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 39 bottles of Risperidone 1mg/mL solution due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 26,895 Proair HFA inhalers due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 53 bottles of Vitamin D3 25mcg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 237 bottles of Phentermine HCL 37.5mg capsules due to intermittent temperature exposure during storage.
Cardinal Health is recalling 122 Asmanex Twistero inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.
Cardinal Health Inc. is recalling 796 bottles of VIMPAT (lacosamide) 100 mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 903 Trelegy Ellipta inhalers distributed in Florida, Georgia, and South Carolina due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 6 boxes of Cyanocobal Injection 1000mcg/mL due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 19 bottles of Vitamin D3 25mcg tablets because they were intermittently exposed to temperature excursions during storage.
Cardinal Health is recalling 29 bottles of Eszopiclone 3mg tablets due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling Corgard (nadolol) 40 mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 35 bottles of Haloperidol 20mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health is recalling 210 cartons of Orilissa (elagolix) tablets due to intermittent exposure to temperature excursions during storage.