Agency classClass IIIOur severity:Low FDA (Drugs)·D-016-2014·Announced 2013-12-04

Fresenius Kabi Recalls Paclitaxel Injection Due to Missing Package Insert Text

Fresenius Kabi USA, LLC is recalling 71,129 vials of Paclitaxel Injection because the package insert is missing text in the Clinical Studies and Specific Adverse Events sections.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling defect rather than a direct safety hazard.

Plain-English summary

Fresenius Kabi USA, LLC is recalling 71,129 vials of Paclitaxel Injection, USP (300 mg/50 mL; 6 mg/mL). The product is a multiple-dose vial intended for intravenous use and is manufactured for APP Pharmaceuticals, LLC. The recall is due to a labeling error where the product insert is missing text in the "Clinical Studies" and "Specific Adverse Events" sections.

The affected product is distributed nationwide in the United States and in Puerto Rico. The recall involves specific lots with expiration dates of 11/13 and 12/13. The product is a prescription-only medication classified as a human prescription drug.

Healthcare providers and patients should check their inventory for the affected lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the supplier or the recalling firm. This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product: PACLITAXEL (PACLITAXEL)
Brand: PACLITAXEL
Manufacturer: Fresenius Kabi USA, LLC
Category: Drug — Prescription Injection
Hazard: mis-labeling
Affected units: 71,129

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

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

UPCs (2)

0363323763503
0363323763169

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · PACLITAXEL

High
Hospira Recalls Paclitaxel Injection Due to Embedded Glass Particles
FDA (Drugs) · 2012-09-26

Same manufacturer · Fresenius Kabi USA, LLC

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