Class II · Moderate risk
Colgate Total SF Toothpaste
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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
CITALOPRAM Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
CHLORTHALIDONE Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Bumetanide Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Low Dose ASPIRIN
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Asmanex Twisthaler
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Armour Thyroid
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
AMOXICILLIN Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
AMOXICILLIN for Oral Suspension USP
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
ALLOPURINOL Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
ALBUTEROL SULFATE IN 90MCG per actuation
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
ALBUTEROL SULFATE HFA Inhalation Aerosol
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class I · High risk
Enoxaparin Sodium Injection
Temperature Abuse; temperature excursion during shipping
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class II · Moderate risk
Sodium Chloride 0.9%
Temperature Abuse: Product exposed to temperature outside specified limits.
Class I · High risk
Xultophy 100/3.6
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
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