Class II · Moderate risk
Ilevro (nepafenac ophthalmic suspension)
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
Tobrex 0.3% 3.5gm Opth
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Vitamin D3 Cholecalciferol 50
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Vitamin D3 Cholecalciferol 50
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nat B Vit D3 2000u 100
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Proctofoam HC
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Epinephrine Injection
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Estradiol Transdermal System
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Levothyroxine Sodium Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Asmanex Twst 220mcg 60inh Pwd
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Steglatro (ertugliflozin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Belsomra (suvorexant)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Belsomra (suvorexant)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Pedia-Lax 66ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Carbidopa and Levordopa Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Vitamin D3 50mcg 100 Calc
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Benzoyl Peroxide Wash 5% 148ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment 28gm
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Vitamin D3 25mcg 180 Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Vitamin D3 25mcg 90 Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Vitamin D3 50mcg 100 Softgels
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Acne Medication Benzoyl Peroxide Gel USP
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Miconazole 7 2% 45gm Apl
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Trazodone Hydrochloride Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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