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

Recall Number: D-016-2014

Firm: Fresenius Kabi USA, LLC

Classification: Class III

Status: Terminated

Report Date: 20131204

Initiation Date: 20131108

Termination Date: 20150512

Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.

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