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carboplatin FDA Alerts

The FDA Alert(s) below may be specifically about carboplatin or relate to a group or class of drugs which include carboplatin.

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. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for carboplatin

Injectable Products by Mylan: Recall - Presence of Particulate Matter

Apr 24, 2015

Audience: Pharmacy, Oncology, Rheumatology

including certain lots of:

See the press release for a listing of the product strength, NDC, and lot numbers affected by this recall. Some products may be packaged with a Pfizer Injectables label (see Background below)

 

[Posted 04/24/2015]

ISSUE: Mylan N.V. is conducting a voluntary nationwide recall to the hospital/user level of select lots of injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples.

Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Intrathecal administration could result in a life threatening adverse event or result in permanent impairment of a body function. Intravenous administration has the potential to damage and/or obstruct blood vessels which could induce emboli, particularly in the lungs. If a right to left cardiac shunt is present, the particulate may lead to arterial emboli and result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function or tissue necrosis. Other adverse effects associated with intravenous injection of particulate matter include local inflammation, phlebitis, allergic response and/or embolization in the body and infection. Intra-arterial administration could result in damage to blood vessels in the distal extremities or organs. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation.

BACKGROUND: Gemcitabine for Injection, USP 200mg is an intravenously administered product indicated for the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and pancreatic cancer. These lots were distributed in the U.S. between Feb. 18, 2014, and Dec. 19, 2014, and were manufactured and packaged by Agila Onco Therapies Limited, a Mylan company. Lot 7801089 is packaged with a Pfizer Injectable label.

Carboplatin Injection 10mg/mL is an intravenously administered product indicated for the treatment of advanced ovarian carcinoma. The lot was distributed in the U.S. between Aug. 11, 2014, and Oct. 7, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company, with a Mylan Institutional label.

Methotrexate Injection, USP 25mg/mL can be administered intramuscularly, intravenously, intra-arterially, or intrathecally and is indicated for certain neoplastic diseases, severe psoriasis and adult rheumatoid arthritis. The lot was distributed in the U.S. between Jan. 16, 2014, and March 25, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company, with a Pfizer Injectables label.

Cytarabine Injection can be administered intravenously or intrathecally and in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. The lot was distributed in the U.S. between May 02, 2014, and July 24, 2014, and was manufactured and packaged by Agila Onco Therapies Limited, a Mylan company located in Bangalore, India and is packaged with a Pfizer Injectables label.

RECOMMENDATION: Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Distributors, retailers, hospitals, clinics, and physicians that have these products which are being recalled should stop use and return to place of purchase. Consumers with questions regarding this recall can contact Mylan Customer Relations at 800.796.9526 or customer.service@mylan.com, Monday through Friday from 8 a.m. - 5 p.m. EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • 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


[04/23/2015 - Press Release - Mylan]

Carboplatin Injection by Hospira: Recall - Visible Particulate Matter Identified

Dec 15, 2012

Audience: Pharmacy, Patient, Health Professional

ISSUE: Hospira, Inc. is further informing the general public about a previously communicated voluntary user-level recall of three lots of Carboplatin Injection due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. If particulate matter from crystallization is injected into a patient, it may potentially become lodged in and obstruct blood vessels, potentially causing local infarction, thromboembolism and vasculitis. Chronically, following sequestration, granulomatous formation in the lungs is possible.

BACKGROUND: Carboplatin Injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. Carboplatin Injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with Cisplatin.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-650-8362 between the hours of 8am and 5pm EST, Monday through Friday, to arrange for the return of the product.

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • 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

[12/14/2012 - Firm Press Release - Hospira]

[07/13/2012 - Firm Press Release - Hospira]

Hospira Injectable Drug Products: Recall - Visible Particulates from Defective Glass Vials

Jul 16, 2012

Audience: Risk Manager, Pharmacy

Including certain lots of the following products:

[Posted 07/16/2012]

ISSUE: Hospira and FDA notified healthcare professional of a nationwide recall of certain injectable drug products, due to visible particles embedded in the glass located at the neck of the vial. There may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. In the event in which particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Signs and symptoms might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms.

See the Press Release for a listing of affected product lot numbers and expiration dates.

BACKGROUND: These products were distributed nationwide to wholesalers and direct customers. Hospira completed an investigation and attributed the root cause to a supplier glass defect. Hospira is arranging for return/replacement etc. of all recalled products. Formal recall letters have been distributed within the US along with notification to safety organizations.

RECOMMENDATION: Anyone with an existing inventory in the United States should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-628-0734 between the hours of 8am to 5pm EDT, Monday through Friday, to arrange for the return of the product.


[07/13/2012 - Press Release - Hospira, Inc]

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