Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Super-Potent Drug: Out of specification potency results were obtained.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of Assurance of Sterility
Presence of foreign substance: Presence of Benzene.
Failed Dissolution Specifications
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Presence of Foreign Tablets/Capsules.