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 52 bottles of Jentadueto XR tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 75 bottles of Benicar 40mg tablets due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 298 bottles of Lithium Carbonate 150mg capsules due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 37 bottles of Tylenol Acetaminophen Liquid Gels because of intermittent temperature exposure during storage.
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 51 bottles of Methocarbamol 500mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 37 bottles of Darifenacin Extended-release Tablets 15 mg due to intermittent 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 92 bottles of Sulindac 200mg tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 321 bottles of Fexofenadine Hydrochloride 180 mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 72 tubes of Vaniqa cream distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.
Cardinal Health is recalling 422 bottles of Infants Aqueous Vitamin D Oral Drops due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 147 units of Pedia-Lax 66ml enemas due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 96 cartons of Belbuca buccal film due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 345 cartons of Ibuprofen Oral Suspension USP 100mg/5ml due to intermittent 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 1,278 bottles of Brilinta (ticagrelor) 60 mg tablets 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 Inc. is recalling 131 bottles of Lamotrigine Extended-Release Tablets 250 mg due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 424 bottles of Atropine Sulfate Ophthalmic Solution 1% due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 122 bottles of Acetazolamide Tablets 125 mg due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling 407 boxes of Carbipoda and Levodopa Tablets due to intermittent temperature excursions during storage.
Cardinal Health Inc. is recalling Hydrocortisone Acetate 30mg suppositories due to intermittent exposure to temperature excursions during storage.
Cardinal Health Inc. is recalling 33 bottles of Amlodipine and Olmesartan Medoxomil Tablets due to intermittent temperature excursions during storage.
Cardinal Health is recalling 78 bottles of Siladryl 12.5/5ml liquid because of intermittent temperature excursions during storage.