Class II · Moderate risk
Gastrografin
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
E-Z-Gas II
cGMP deviations: Temperature abuse
Class II · Moderate risk
E-Z-HD (Barium Sulfate for Oral Suspension)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Transderm Scop
cGMP deviations: Temperature abuse
Class II · Moderate risk
Recothrom Thrombin Topical
cGMP deviations: Temperature abuse
Class II · Moderate risk
Revonto (dantrolene sodium for injection)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Revonto (dantrolene sodium for injection)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Vecuronium Bromide for Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Propofol Injectable Emulsion
cGMP deviations: Temperature abuse
Class II · Moderate risk
Propofol Injectable Emulsion
cGMP deviations: Temperature abuse
Class II · Moderate risk
Proair
cGMP deviations: Temperature abuse
Class II · Moderate risk
Mupirocin Ointment
cGMP deviations: Temperature abuse
Class II · Moderate risk
MethyLPREDNISolone Acetate Injectable Suspension USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
MethyLPREDNISolone Acetate Injectable Suspension USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
MethyLPREDNISolone Acetate Injectable Suspension USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
MethyLPREDNISolone Acetate Injectable Suspension
cGMP deviations: Temperature abuse
Class II · Moderate risk
MethyLPREDNISolone Acetate Injectable Suspension
cGMP deviations: Temperature abuse
Class II · Moderate risk
Medroxyprogesterone acetate injectable suspension
cGMP deviations: Temperature abuse
Class II · Moderate risk
Lidocaine Patch 5%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Levalbuterol Tartrate HFA Inhalation Aerosol
cGMP deviations: Temperature abuse
Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ketoconazole Cream
cGMP deviations: Temperature abuse
Class II · Moderate risk
MethyLPREDNISolone Acetate Injectable Suspension USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
MethyLPREDNISolone Acetate Injectable Suspension
cGMP deviations: Temperature abuse
Class II · Moderate risk
MethyLPREDNISolone Acetate Injectable Suspension
cGMP deviations: Temperature abuse
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