557 recalls, newest first
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP Deviations: Released product should have been rejected.
Reason Labeling: Not Elsewhere Classified - Wrong NDC number
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Reason CGMP Deviations: lack of adequate release testing.
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason Subpotent drug
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Reason Failed Impurity/Degradation Specifications
Reason Failed Impurity/Degradation Specifications
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason cGMP Deviations: Out of specification results for micro in hand soap products.