# FDA recall D-016-2014

> **Fresenius Kabi USA, LLC** · Class III · drug recall initiated 2013-11-08.

## 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

- **Recall number:** D-016-2014
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-016-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-016-2014. Source: US FDA. Licensed CC0.

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