Class II · Moderate risk
Synjardy XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Temperature excursions
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled.
569 FDA drug recalls with this cause, newest first.
Vaccines, insulin, many injectables and some tablets must stay within a narrow temperature band from factory to pharmacy. A truck without working refrigeration, a freezer failure or a warehouse heatwave is enough: the product looks normal but may have lost potency or formed degradation products. FDA files these under 'CGMP deviations' or 'temperature abuse'; we track them separately because the question to ask - how was my medication stored? - is different from every other cause.
Class II · Moderate risk
Synjardy XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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.
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