Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only Recalled by Eagle Pharmaceuticals Inc. Due to A complaint was received from a hospital pharmacy...

Date: December 2, 2011
Company: Eagle Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Eagle Pharmaceuticals Inc. directly.

Affected Products

Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA

Quantity: 19,660 vials

Why Was This Recalled?

A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.

Where Was This Sold?

New Jersey

About Eagle Pharmaceuticals Inc.

Eagle Pharmaceuticals Inc. has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report