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)

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: 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)

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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)

03/23/2012 11:06 AM EDT

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.

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