Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0186-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0185-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0184-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0183-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0182-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0181-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0180-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0179-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0178-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0177-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0176-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0175-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0174-2015
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
TerminatedSterility / contaminationOregon Compounding Centers, Inc. dba Creative CompoundsD-0173-2015
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.