Navigation Links
Zydus Pharmaceuticals USA Inc. Issues Voluntary Nationwide Recall of Warfarin 2 mg Tablets, Lot MM5767, Expiration Date June 2014, Due to Oversized Tablets
Date:6/12/2013

PENNINGTON, New Jersey, June 12, 2013 /PRNewswire/ --

Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin 2 mg Tablets, Lot # MM5767, expiration date June 2014 to the retail level. Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint.

Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding as an adverse reaction and in some patients that bleeding into a critical organ (mostly the central nervous system) could be fatal. The risk of bleeding is increased if overdosing is repeated continuously on a daily basis.

Zydus has not received any reports of adverse events or any additional product complaint related to this lot to date, but as a precautionary measure, Zydus is recalling lot MM5767 from the distribution.

The product is used as prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement and reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Product is packaged in HDPE Bottle of 1000's count, which may have been dispensed to patients in smaller bottles. The only lot affected of Warfarin 2 mg Tablets being recalled is Lot MM5767.

The product can be identified by its NDC # 6838205310.  The product was distributed nationwide in the United States to wholesalers/distributors, retailers and mail order providers, from November 2012 to December 2012.

Zydus has notified its direct account customers by sending the recall notification letter by FedEx next day air service and is working with customers to arrange for product return.

Anyone with an existing inventory of this particular Lot MM5767 of Warfarin 2 mg Tablets should stop use and distribution, quarantine the recalled lots immediately and call INMAR at 1-800-967-5952 between the hours of 7 a.m. to 4 p.m. CST, Monday through Friday, to arrange for their return. In case patients have tablets of this lot of product, make sure all the tablets are of the same size and if unsure, patients should consult their dispensing pharmacy.

If you have any question about product safety issue, then please call Zydus Pharmaceuticals Drug Safety/ Medical Affairs at 1-877-993-8779, Option# 2. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this particular lot of Warfarin 2 mg Tablets.

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

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


'/>"/>
SOURCE Zydus Pharmaceuticals USA Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Zydus fait une percée avec LIPAGLYN, première NEC indienne mise sur le marché
2. Zydus Pioneers a Breakthrough With LIPAGLYN, Indias First NCE to Reach the Market
3. Zydus Demonstra Pioneirismo com o Inovador LIPAGLYN, Primeiro NCE da Índia a Entrar no Mercado
4. Adamas Pharmaceuticals To Report Positive Phase 2/3 Results For ADS-5102 For The Treatment Of Levodopa-Induced Dyskinesia In Parkinsons Disease
5. Access Pharmaceuticals Signs US License Agreement With AMAG Pharmaceuticals For MuGard
6. HemaQuest Pharmaceuticals Completes Patient Enrollment in Phase 2b Clinical Study of HQK-1001 in Patients with Sickle Cell Disease
7. Oramed Pharmaceuticals to Present at IATI-BioMed Conference in Israel
8. DelMar Pharmaceuticals, Inc. Investor Presentation Now Available for On-demand Viewing at RetailInvestorConferences.com
9. Valeant Pharmaceuticals Announces Filing Of Preliminary Base Shelf Prospectus
10. Ampio Pharmaceuticals Issues Statement Regarding Misleading Blog
11. Actinium Pharmaceuticals, Inc. Receives $3.5m from Exercise of Warrants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Pa. , June 23, 2016 Bracket ... will launch its next generation clinical outcomes platform, Bracket eCOA ... Meeting held on June 26 – 30, 2016 in ... the first electronic Clinical Outcome Assessment product of its kind ... Booth #715. Bracket eCOA 6.0 is a flexible ...
(Date:6/23/2016)... and INDIANAPOLIS , June 23, 2016 ... Lilly Diabetes Tomorrow,s Leaders Scholarship is any indication, the ... announced today online at www.diabetesscholars.org by the ... diabetes stand in the way of academic and community ... Foundation,s scholarship program since 2012, and continues to advocate ...
(Date:6/23/2016)... Revolutionary technology includes multi-speaker listening to conquer ... in advanced audiology and hearing aid technology, has today ... world,s first internet connected hearing aid that opens up ...      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) , ... , TwinLink™ - the first dual communication ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... health professionals, announced today its affiliation with Tennessee Counseling Association. This ... the network of the Tennessee Counseling Association, adding exclusive benefits and promotional offers. ...
(Date:6/26/2016)... Battle Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... abuse, joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table ... held in honor of the city’s history as home to some of the world’s ...
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... As a ... Magna Cum Laude and his M.D from the David Geffen School of Medicine at ... returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic ... many turn to unhealthy avenues, such as drug or alcohol abuse, as a coping ... released tools for healthy coping following a traumatic event. , Trauma sufferers tend to ...
Breaking Medicine News(10 mins):