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CGMP Deviations: product held outside appropriate storage temperature conditions.
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.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
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