Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only…
Reason Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
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Reason Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Reason Presence of Particulate Matter; identified as stainless steel
Reason Presence of Particulate Matter; identified as stainless steel
Reason Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…
Reason Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Reason CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Reason Failed Dissolution Specifications
Reason CGMP Deviations:Noted during FDA inspection
Reason CGMP Deviations:Noted during FDA inspection
Reason CGMP Deviations:Noted during FDA inspection
Reason CGMP Deviations:Noted during FDA inspection
Reason CGMP Deviations:Noted during FDA inspection
Reason Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
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