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Adrucil FDA Alerts

The FDA Alerts below may be specifically about Adrucil or relate to a group or class of drugs which include Adrucil.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Adrucil

Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate

July 2, 2019 -- Fresenius Kabi USA, LLC is voluntarily recalling two lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, to the user level due to the potential for glass particulate. The affected lots, distributed between December 6, 2018 and February 20, 2019, are listed below:

Product Name/Size NDC Number Product Code Lot Number Expiration Date First Ship Date Last Ship Date
Fluorouracil Injection,
USP, 5g/100mL (50mg/mL), 100mL
fill in a 100mL vial
63323-117-69 NP101761 6120341 04-2020 12/06/2018 12/18/2018
63323-117-61 101761 6120420 04-2020 12/07/2018 02/20/2019

Products containing glass particulate should not be administered intravenously due to the potential for life-threatening consequences. Reports in the literature suggest that sequelae of thromboembolism, such as pulmonary emboli, phlebitis, granulomas, or fibrosis may occur.

To date, Fresenius Kabi has not received any complaints or reports of adverse events related to this recall.

The company is issuing this notification after finding glass particulate in five vials in retained sample inventory of lot 6120341 during an inspection for a quality investigation. The second lot (6120420) is included in the recall as a precautionary measure as it was produced in the same filling campaign.

Fluorouracil is a chemotherapy drug that is administered intravenously and indicated for the treatment of a variety of cancers.

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius-kabi.com/us/pharmaceutical-product-updates.

Consumers with questions regarding this recall may contact Fresenius Kabi at 1-800-551-7176 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. or via email at productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@freseniuskabi.com Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.

Source: FDA


Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter

[Posted 07/27/2015]

ISSUE: Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected. To date, Teva has not received any reports of adverse events related to this recall. See the press release for product lot numbers affected by this recall.

BACKGROUND: Adrucil Injection is used in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas and is packaged in pharmacy bulk packages.

RECOMMENDATION: Teva is arranging for impacted product to be returned to Inmar. Anyone with an existing inventory of the recalled lots should stop use and distribution, and quarantine the product immediately. Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the user level.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[07/24/2015 - Press Release - Teva Parenteral Medicines]


Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter

ISSUE: Teva Parenteral Medicines issued a voluntary recall of eight lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. See the press release for a listing of affected lot numbers.

Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.

BACKGROUND: Adrucil Injection is used in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas and is packaged in pharmacy bulk packages. The pharmacy bulk package has five 5 g/100ml vials per shelf pack. Individual Adrucil 5 g/100 ml vials have the NDC code 0703-3019-11 and the pharmacy shelf pack has the NDC code 0703-3019-12. The Adrucil 5 g/100 ml vial can be further identified by the statement on the label in red that states "PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION". Adrucil 5 g/100 ml vials were distributed in the United States. Teva has distributed this product through the normal distribution chain of wholesalers, retailers, and pharmacies.

RECOMMENDATION: Anyone with an existing inventory of the recalled lots should stop use and distribution, and quarantine the product immediately. Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the user level.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Teva has notified its direct customers by mail and has issued an Urgent Drug Recall Letter to direct customers. Teva is arranging for impacted product to be returned to Inmar.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[05/04/2015 - Press Release - Teva Parenteral Medicines]
[05/04/2015 - Product Image - FDA]
 


Fluorouracil Injection 50mg/mL, (500 mg/10mL Single Dose Vial)

[Posted 09/27/2005] American Pharmaceutical Partners, Inc. and FDA notified healthcare professionals about a nationwide recall of Fluorouracil Injection 50 mg/mL (500 mg/10ml Single Dose Vial) because of the potential for invisible glass particles containing silica and aluminum in vials of the product. The company states that only Product code 101710 is susceptible to this type of glass breakdown.


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