Recall -- Firm Press Release

 

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Eagle Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 4 Lots of Argatroban Injection 50 mg/50 mL (1 mg/mL) Due to a Potential for Visible Particulates.

NDC# 42367-203-07 (single unit)
NDC# 42367-203-84 (10 pack)

 

Contact:

Consumer:
The Medicines Company
1-888-977-6326
argatrobanrecall@themedco.com

FOR IMMEDIATE RELEASE - December 2, 2011 -The Medicines Company’s supplier, Eagle Pharmaceuticals Inc., has issued a voluntary recall of all four (4) lots of Argatroban Injection, 50 mg per 50 mL (“Argatroban”) from the market due to a potential for visible particulates.

The Medicines Company has not received any reports of adverse events related to this issue. However, due to the possible presence of visible particulates there is a risk of embolization/infarction to organs with potential organ complications.

Eagle Pharmaceuticals Inc. has directed The Medicines Company (“MDCO”) to arrange for the return of the following lots from all services and facilities:

Lot Number	Expiration Date
V10189	Jan. 2013
V10191	Jan. 2013
V10194	Jan. 2013
V10223	Feb. 2013

During the investigation of the only product complaint, a visible particulate was discovered in a stability sample in one of the distributed lots. This discovery prompted a re-inspection of undistributed lots at the manufacturing site. Upon this re-inspection, a small number of visible particulates were discovered in several vials.

Eagle Pharmaceuticals Inc. is conducting this voluntary recall as a precautionary measure with the knowledge of the US Food and Drug Administration (“FDA”). This voluntary recall is being conducted nationwide at the wholesaler, pharmacy and distributor levels.

Any adverse events that may be related to the use of this product should be reported to The Medicines Company at (1-888-977-6326) or to FDA's MedWatch Program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: Use postage-paid, pre-addressed Form FDA 3500
  available at: www.fda.gov/MedWatch/getforms.htm
  Mail to the address on the pre-addressed form.
• Fax:1-800-FDA-0178

If you have questions regarding this voluntary recall or the return of recalled product, please contact The Medicines Company at 1-888-977-6326 or argatrobanrecall@themedco.com.

 

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