Class II · Moderate risk
Dihydroergotamine Mesylate
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
Epidural Tray
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ampicillin for Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betadine 5%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Sumatriptan Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Arzol (Silver Nitrate Applicator)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Olanzapine single dose vial Lyophilized
cGMP deviations: Temperature abuse
Class II · Moderate risk
Lidocaine Patch
cGMP deviations: Temperature abuse
Class II · Moderate risk
Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Azithromycin for Injection USP Vial
cGMP deviations: Temperature abuse
Class II · Moderate risk
Topex (benzocaine 20%)
cGMP deviations: Temperature abuse
Class II · Moderate risk
TobraDex (tobramycin and dexamethasone)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Miocol-E (acetylcholine chloride intraocular solution)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Epi-Pen 2-Pak
cGMP deviations: Temperature abuse
Class II · Moderate risk
Trulicity (dulaglutide)
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Class II · Moderate risk
Trulicity (dulaglutide)
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · High risk
Humalog KwikPen
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class II · Moderate risk
Inhub Wixela
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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