Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Rising Pharma Holding
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class I - Dangerous
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class I - Dangerous
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Presence of Foreign Tablets/Capsules