23 FDA recalls mention Sufentanil. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sufentanil.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Reason Non-Sterility
Reason Non-Sterility
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Reason Lack of sterility assurance.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because…
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