Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals…
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
8 FDA recalls mention Docetaxel. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Docetaxel.
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Reason CGMP Deviations
Reason Lack of Assurance of Sterility
Reason Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Reason Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Reason Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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