Olanzapine Tablets
Failed Impurities/Degradation Specifications
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Failed Impurities/Degradation Specifications
Failed Stability Specifications
CGMP deviations: out of specifications for assay
Discoloration
Failed Impurities/Degradation Specifications
CGMP Deviations: Inconsistency in the water systems.
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
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
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained