Navigation Links
American Regent Initiates Nationwide Voluntary Recall of Sterile Water for Injection, USP, 50 mL Single Dose Vial Due to Particulate Matter
Date:5/19/2011

SHIRLEY, N.Y., May 19, 2011 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:

Sterile Water for Injection, USP, 50 mL Single Dose Vial,

NDC # 0517-3050-25, Lot 0092, Exp. Date February, 2014



PLEASE NOTE: This recall, initiated on May 19, 2011 to the User or Consumer Level, is for Lot 0092 Only. No other lots or sizes of Sterile Water for Injection, USP are subject to this voluntary recall.

This voluntary recall was initiated because some of the vials of this lot may contain rust like particulate matter. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues, if this lot of Sterile Water for Injection, USP is administered to patients.

Sterile Water for Injection, USP is to be used only as a diluent. It is not isotonic and should not be injected directly into the body.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, Emergency Rooms, Clinics, Physician Offices and other healthcare facilities and providers should not use American Regent Inc., Sterile Water for Injection, USP, 50 mL Single Dose Vials, with Lot 0092, for patient care and should immediately quarantine any product for return.

American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned product with lot 0092. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM EDT.

Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via email at pv@luitpold.com by fax to (610) 650-0170 or by phone at 1-800-734-9236. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR PHONE.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, or regular mail or by fax.


While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.

As is standard practice, and as stated in the Sterile Water for Injection, USP, Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."

Sterile Water for Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


'/>"/>
SOURCE Luitpold Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Genomic Health Announces Ten Studies Covering Breast, Colon and Prostate Cancers Accepted for Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting
2. Dendreon Announces Clinical Trial Plans for PROVENGE and DN24-02 at the American Society of Clinical Oncology Annual Meeting
3. Dendreon Announces Presentation of PROVENGE Data at the 2011 American Society of Clinical Oncology Annual Meeting
4. ARX-01 and ARX-03 Clinical Results Presented at the 30th Annual Scientific Meeting of the American Pain Society
5. Nexavar Data to Be Presented at American Society of Clinical Oncology Annual Meeting
6. Onyx Pharmaceuticals Announces Data Presentations of Carfilzomib and ONX 0912 at 47th American Society of Clinical Oncology Annual Meeting
7. Bayer to Present Data on Investigational Oncology Compounds at 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO)
8. Positive Results from Long-Term Phase 3 Study of Avanafil Featured at American Urological Association Annual Meeting
9. Inovio Pharmaceuticals to Present at American Society of Gene & Cell Therapy Annual Meeting May 18 - 21, 2011
10. VIDA Diagnostics Launches Apollo Pulmonary Analysis Software for Major Lung Disease at American Thoracic Society Meeting
11. Accuray Showcases CyberKnife Robotic Radiosurgery System at American Urological Association Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2017)... HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, platform ... leadership team developments today:   ... ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has led ...
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017 ... , and OptiMed Specialty Pharmacy of Kalamazoo, ... offer a strategic hub service that expedites and streamlines ... personal spirometer, Spiro PD 2.0, and wellness management services.  ... is a medical device used to measure lung function ...
(Date:9/13/2017)... --  OrthoAtlanta has been named the official orthopedic and ... for the 2018 College Football Playoff (CFP) National Championship to ... in Atlanta, Georgia . OrthoAtlanta is proud ... participating in many activities leading up to, and including the ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... As health ... medicine known as “patient engagement.” The patient is doing more than filling out a ... , “There is an increasing emphasis in health care and research on the ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... PurhealthRX ... CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will ... and providing a CBD form that can be easily incorporated into liquid products, while ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Many families ... However, many long-term care insurance companies have a waiver for care if the client ... elimination period, when the family pays for care, is often waived, so the benefits ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and ... explains one of the most popular and least understood books in the Holy Scriptures, ... puzzling descriptions that have baffled scholars for centuries. Many have tossed it off as ...
(Date:10/13/2017)... ... , ... “America On The Brink”: the Christian history of the United States ... creation of published author, William Nowers. Captain Nowers and his wife, Millie, have ... thirty years in the Navy. Following his career as a naval aviator and ...
Breaking Medicine News(10 mins):