DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for…
Reason Presence of Particulate matter: Particulate matter identified as glass.
162 FDA recalls mention Star. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Star.
Reason Presence of Particulate matter: Particulate matter identified as glass.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Stability Data Does Not Support Expiry Date.
Reason Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Reason CGMP Deviations
Reason cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
Reason cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
Reason cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
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