Class II · Moderate risk
Minivelle (estradiol transdermal system)
Temperature Abuse: Prolonged exposure to temperatures outside of 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
Vancomycin Hydrochloride for Injection
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I · High risk
Propofol Injectable Emulsion
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class II · Moderate risk
Ketorolac Tromethamine Inj.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class II · Moderate risk
Amiodarone HCl Injection
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
Class II · Moderate risk
Benicar HCT Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Benicar HCT Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Benicar Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Welchol Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk
Tribenzor Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk
Benicar HCT Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk
Benicar Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk
Azor Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk
HydrOXYzine Hydrochloride Oral Solution
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Class III · Low risk
Bumetanide Tablets USP 0.5 mg. Rx Only
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Class II · Moderate risk
Ifosfamide Injection 3g/60 mL
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Class II · Moderate risk
Ifosfamide Injection 1g/20mL
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
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