CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle