Lansoprazole Delayed-Release Orally Disintegrating Tablets
Failed Dissolution Specifications
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Failed Dissolution Specifications
Failed viscosity specification - product was below specificcation
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
cGMP Deviations
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse