Particulate Matter Contamination Leads to Argatroban Recall

|

Four lots of the blood thinner Argatroban have been recalled due to particulate matter contamination. 

The Argatroban recall was announced by the FDA on March 23, after visible particles were spotted in some vials during inspections that occurred after the distributor received a complaint. The recall was issued by Eagle Pharmaceuticals, Inc., supplier to The Medicines Company.

Argatroban is an anticoagulant used to prevent or treat thrombosis caused by the drug heparin. It was first approved by the FDA in 2000.

Sports-Betting-Addiction-Lawsuits
Sports-Betting-Addiction-Lawsuits

The FDA warns that the risk of using an injectable drug that has been contaminated with particulate matter could include embolization and infarction to organs, which could cause severe injury. There have been no reports of injuries related to the recalled Argatroban.

Four lots of Argatroban Injection, 50 mg per 50 mL, are affected by the recall, including lot numbers V10189, V10191 and V10194 with expiration dates of Jan 2013, and lot number V10223 with an expiration date of Feb 2013.

Eagle Pharmaceuticals Inc. has asked The Medicines Company to arrange for the affected vials to be returned from services and facilities that received them. The recall is being conducted at the wholesaler, pharmacy and distributor levels.

Customers with questions can contact The Medicines Company at (888) 977-6326 or via e-mail at argatrobanrecall@themedco.com. Adverse events related to the use of this product should be reported to the FDA’s adverse event reporting program, MedWatch.


0 Comments


Share Your Comments

This field is hidden when viewing the form
I authorize the above comments be posted on this page
Post Comment
Weekly Digest Opt-In

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

MORE TOP STORIES

As the Depo-Provera MDL moves toward its first jury trials, the litigation has reached a key milestone, with more than 550 lawsuits filed over brain tumor injuries linked to the birth control injection.