Argatroban Injections (1mg/ml) Recalled For Possible Visible Particles

The FDA is alerting all medical professionals and especially hematologists and pharmacists of the voluntary recall for Eagle Pharmaceuticals’ Argatroban Injections (1mg/ml) due to the risk of possible visible particles.

Argatroban Injection

Background of Argatroban Injections

Argatroban injections are manufactured by Eagle Pharmaceuticals Inc., the company that voluntarily recalled these products.

The concerned injections are mostly employed by hematologists and pharmacists in their practice.

FDA Alert on the recall for Argatroban Injections

This recall was voluntarily initiated by the manufacturer of Argatroban Injections identified the presence of visible particles in the injection vials.

Details of the affected products are as follows:

• Name: Argatroban Injection

• Quantity: 1mg/ml or 50mg/50ml – 1mg per 1ml or 50mg per 50ml

• No. of Lots: 4 (four)

• Product No.:
  • 1 unit pack of: #NDC 42367-203-07
  • 10 unit pack of: #NDC 42367-203-84

• Lot No.:

LOT No.

EXPIRY   DATE

V10189

January 2013

V10191

January 2013

V10194

January 2013

V10223

February 2013

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Following the establishment of the visible particles in Argatroban Injection vials, the affected distributed lots were recalled while the undistributed lots were taken in for re-inspecting.

The re-inspection of some of these undistributed injection vials further revealed the presence of the particulate matter that’s visible in several batches; a finding that thereby went to support an analysis of one of the stability samples that first identified the presence of visible particulate matter in the Argatroban Injection.

Risks identified with the recalled Argatroban Injections

There are various medical health risks associated with the recalled injections by Eagle Pharmaceuticals, Argatroban, and these include:

• Embolization which may either be:
  • Arterial embolization (introduction of a foreign unwanted or abnormal particle into the blood circulation via an artery during its administration with an injection)
  • Venous embolism (introduction of a foreign unwanted or abnormal particle into the blood circulation via a vein during its administration with an injection)
• Organ Infarction (intruding system organs with foreign and/or visible particulate matter
• Organ damage or complications in the normal functioning or condition of the system organs

FDA Recommendation on recalled Argatroban Injections

• “Eagle Pharmaceuticals Inc. directed The Medicines Company (“MDCO”) to arrange for the return of the affected product lots from all services and facilities.
• See the Press Release for a listing of affected lots.”

Contacting the FDA to report cases with Argatroban Injections

Any adverse side effects or incidences relating to Argatroban Injections from Eagle Pharmaceuticals should immediately be reported to the FDA in the event that a patient or medical professional experiences this.

This should be done by contacting or informing the FDA’s MedWatch Safety Information & Adverse Event Reporting Program through any of the following ways:

• Filling and submitting an online report at: http://www.fda.gov/MedWatch/report.htm
• Download the case reporting form at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Dialing 1-800-332-1088 and requesting to get a report form, filling it and returning it to the address indicated on the form
• Faxing the filled-up form to the fax number: 1-800-FDA-0178

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