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cGMP Deviations; product does not comply with cGMP requirements
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Crystallization; identified as calcium salt of Ketorolac
May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
"The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. "L" and "R" of scan images are reversed and this is not consistent with the patient actual position. "When a surview which is longe
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.