December 2011 FDA Recall Drug by Eagle Pharmaceuticals Inc.
D-1429-2012 - 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.

This Class I drug recall was voluntarily initiated by Eagle Pharmaceuticals Inc. on December 2, 2011 for the product Drug. The FDA reported the reason for recall as 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.. The product was distributed in New Jersey and the recall is currently terminated.

Recall Number: D-1429-2012

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.
Initiated
12-02-2011
Reported
08-08-2012
Quantity
19,660 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61108
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Eagle Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New Jersey
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-03-2013
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# V10189
Lot# V10191
Lot# V10194, Exp 01/13
Lot# V10223; Exp 02/13