June 2019 FDA Recall Fluorouracil by Fresenius Kabi Usa, Llc
D-1489-2019 - Presence of Particulate Matter; glass particulates

This Class I drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on June 28, 2019 for the product Fluorouracil. The FDA reported the reason for recall as presence of particulate matter; glass particulates. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1489-2019

Reason for Recall
Presence of Particulate Matter; glass particulates
Initiated
06-28-2019
Reported
07-24-2019
Quantity
14,016 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83234
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
Nationwide USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-20-2022
Product Description About Product Description
Full technical description of the product.
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]

Batch or Lot Expiration Information

Lot# Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761

Affected Packages Involved in this Recall

63323-117-51 Fluorouracil
63323-117-61 Fluorouracil
63323-117-59 Fluorouracil
63323-117-69 Fluorouracil