Class II · Moderate risk
Synjardy XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Jentadueto XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synjardy (empagliflozin and metformin hydrochloride)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Glyxambi (empagliflozin and linagliptin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Atrovent Hfa 17mcg 12.9gm
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Spiriva HandiHaler
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Catapres-Tts-2 1x4
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nurtec Odt
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
SYMPROIC (Naidemedine)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Belbuca (buprenorphine hydrochloride)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Belbuca (buprenorphine hydrochloride)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Dexameth Sod Phos 0.1% 5ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Tobramy/Dex 0.3-0.1% 10ml Opth
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Muro-128 2% 15ml Opth
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Benzefoam Emollient Foam Benzoyl Peroxide 5.3% 100gm Top Emol NDC 187-0194--10
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Lotemax Sm
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nuedexta (dextromethorphan HBr and quinidine sulfate)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Eszopiclone 3mg 100 C4
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ondansetron HCL 4mg 30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Amoxicillin 500mg 100
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Eletriptan Hydrobromide Tablets 20 mg* 6
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ibuprofen Oral Suspension USP 100mg/5ml 120ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
xigduo XR (dapagliflozin/metformin HCl extended-release)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
xigduo XR (dapgliflozin/metformin HCl extended-release)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Bevespi Aerosphere
CGMP Deviations: Intermittent exposure to temperature excursion during storage.