# FDA recall D-1429-2012

> **Eagle Pharmaceuticals Inc.** · Class I · drug recall initiated 2011-12-02.

## Product

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

## Reason for recall

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.

## Distribution

New Jersey

## Key facts

- **Recall number:** D-1429-2012
- **Recalling firm:** Eagle Pharmaceuticals Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2011-12-02
- **Report date:** 2012-08-08
- **Termination date:** 2013-06-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Woodcliff Lake, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1429-2012

## Citation

> AI Analytics. FDA recall D-1429-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1429-2012. Source: US FDA. Licensed CC0.

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