Product: PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50);  Rx Only; Manufactured for  APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India
Reason for recall: Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Recall initiated: 20131108
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated