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Cytosar FDA Alerts

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

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 Cytosar

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:


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

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]

Cytarabine for Injection, 1 gm/vial [Bedford Labs]: Recall: Risk of Lack of Sterility

Feb 23, 2012 | Audience: Pharmacy, Oncology, Risk Manager

ISSUE: Bedford Laboratories announced a nationwide recall of three lots of cytarabine for injection—2066986, 2111675, and 2131148—because vials have a potential risk of a lack of sterility. The risk was determined from a post-release investigation of the manufacturing area.

BACKGROUND: Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningeal leukemia.

RECOMMENDATIONS: Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lots listed for patient care and should immediately quarantine any product for return. Should wholesalers/distributors/retailers still have product which is being recalled, they should stop use and contact Bedford Laboratories Client Services at 800.562.4797.

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • 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

[02/23/12 - Recall Notice - FDA]