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RediTrex FDA Alerts

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

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 RediTrex

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]

Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials

May 21, 2013 | Audience: Pharmacy, Patient, Health Professional

ISSUE: Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. Parenteral injection of drug from the affected lots can lead to microembolisation in areas where the particles lodge. Clinical symptoms are not to be expected from these
microemboli and Sandoz is not aware of any reports of related adverse events.

BACKGROUND: Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). These lots were distributed nationally across the US and to a single foreign country (Poland).

RECOMMENDATION: In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their healthcare professional as well as Sandoz to report the finding. The Sandoz Drug Information Direct Line is open at 800-525-2492, 24 hours/day, seven days a week, or reports can be made via email at qa.druginfo@sandoz.com.

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:

[05/20/2013- Firm Press Release - Sandoz]

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]

Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates

Oct 29, 2010 | Audience: Pharmacy, Risk Manager

ISSUE: Sandoz and FDA notified healthcare professionals of a recall of Methotrexate Injection, 50mg/2mL and 250mg/10mL vials, due to small glass flakes detected in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of the two dosage presentations.

Parenteral injection of drug from the affected lots could lead to serious adverse events in areas where the particles lodge. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. Neurologic damage could result from intrathecal administration.

BACKGROUND: Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.

RECOMMENDATION: Customers and patients should immediately discontinue use of this product and patients should contact their physician or healthcare provider if they experience any problem that might be related to the use of this product. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Product lot numbers, label type, expiration dates, and recall instructions are listed in the Press Release.

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:

 

[10/21/2010 - Press Release - Sandoz Inc.]

    

Methotrexate for Injection (preservative free)

Dec 13, 2005 | Audience: Oncologists, dermatologists, rheumatologists, and other healthcare professionals[Posted 12/13/2005] FDA and Bedford Laboratories, a division of Ben Venue Laboratories, Inc., Bedford, Ohio, announced that it is voluntarily recalling one lot of Methotrexate for Injection (preservative free), USP 1 gram per vial (NDC 55390-143-01), Lot # 859142, exp 09/07, because the active drug substance (“ADS”) used to manufacture Lot # 859142, contained low levels of ethylene glycol. Preservative-free methotrexate is the only formulation that is acceptable for intrathecal administration. Healthcare professionals and suppliers should not distribute these vials and should contact Bedford Laboratories for return instructions. Consumers that have received this product and have questions should contact their physicians.

[December 8, 2005 - Press Release - Bedford Laboratories]

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