Class II · Moderate risk
MIOSTAT (Carbachol Intraocular Solution, USP)
cGMP deviations: Temperature abuse
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
Isopto Atropine
cGMP deviations: Temperature abuse
Class II · Moderate risk
BSS Sterile Irrigating Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
BSS Sterile Irrigating Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
Doxycycline Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
Sterile Water for Injection USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Spinal Tray
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution 0.3%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betamethasone Dipropionate Cream USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Aprepitant Capsule
cGMP deviations: Temperature abuse
Class II · Moderate risk
Aparaclonidine Ophthalmic Solution 0.5% as base
cGMP deviations: Temperature abuse
Class II · Moderate risk
Amoxicillin Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Aerosol HFA 90 mcg
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator
cGMP deviations: Temperature abuse
Class II · Moderate risk
Adrenalin (epinephrine injection, USP)
cGMP deviations: Temperature abuse
Class III · Low risk
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution 0.083%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution 0.083%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
GlucaGen (glucagon)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Firmagon (degarelix for injection)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Firmagon (degarelix for injection)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Epinephrine Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Epinephrine Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
EPI-Pen Jr
cGMP deviations: Temperature abuse
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