November 2013 FDA Recall Paclitaxel by Fresenius Kabi Usa, Llc
D-016-2014 - Labeling

This Class III drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on November 8, 2013 for the product Paclitaxel. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-016-2014

Reason for Recall
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Initiated
11-08-2013
Reported
12-04-2013
Quantity
71,129 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66810
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US: Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-12-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 871ZA00201, Exp 11/13
Lot# 871ZA00301, Exp 11/13
Lot# 871ZA00302, Exp 11/13
Lot# 871ZA00401, Exp 11/13
Lot# 871ZA00402, Exp 11/13
Lot# 872ZA00101, Exp 12/13
Lot# 872ZA00201, Exp 12/13
Lot# 872ZA00301, Exp 12/13
Lot# 872ZA00401, Exp 12/13
Lot# 872ZA00501, Exp 12/13

Affected Packages Involved in this Recall

63323-763-05 Paclitaxel
63323-763-16 Paclitaxel
63323-763-50 Paclitaxel