14,450 recalls · Class II, 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 bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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 bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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 bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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 bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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 bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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 bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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 bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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 bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Reason CGMP Deviations: Released product should have been rejected.
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