FDA recall D-016-2014

Fresenius Kabi USA, LLC · Class III · drug

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.

Distribution

US: Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-11-08
Report date: 2013-12-04
Termination date: 2015-05-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-016-2014