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Argatroban Injection Recall

The U.S. Food & Drug Administration has issued a recall of several lots of Argatroban injections due to contamination by its supplier, Eagle Pharmaceuticals. The Medicines Company, supplied by Eagle Pharmaceuticals, issued a press release urging those who may have purchased the affected product to return it for a replacement.

Argatroban is  blood thinner, similar to Pradaxa,  used to dilate blood vessels in the heart during operations. It works by stopping thrombin, a protein that causes clotting, from producing dangerous clots that can cause gangrene, heart attacks, and strokes. It is used in place of the drug heparin in patients who have had adverse heparin reactions.

After one product complaint of particulates found in a vial of Argatroban Injection, a few other vials were found to have visible particulates. Injected solutions should be completely free of particulates to ensure sterility. Particulates can cause embolization or infarction to organs, resulting in serious organ complications.

The following lots of Argatroban Injection have been recalled:

  • LotV10189; expiration date January 2013
  • LotV10191; expiration date January 2013
  • Lot V10194; expiration date January 2013
  • LotV10223; expiration date February 2013

If you have any contaminated Argatroban Injections, you are urged to contact The Medicines Company at 1-888-977-6325, or email [email protected].