Navigation Links
Ortho Biotech, L.P. and Centocor, Inc. Alert Authorized Distributors and Prescribing Physicians About Stolen Product
Date:5/15/2008

HORSHAM, Pa., May 15 /PRNewswire/ -- JOM Pharmaceutical Services, Inc. (JOM), a service coordinator that provides delivery services and customer support to Centocor, Inc. and Ortho Biotech, L.P., was notified May 6, 2008, that a transport trailer carrying DOXIL(R) (doxorubicin HCl liposome injection), PROCRIT(R) (epoetin alfa) and REMICADE(R) (infliximab) was stolen while the driver was traveling from a distribution center in Kentucky to a specialty distributor. This incident has been reported to local and federal law enforcement offices, as well as the U.S. Food and Drug Administration; however, the transport trailer and product have not yet been recovered.

To ensure patient safety, Centocor and Ortho Biotech are voluntarily withdrawing products with lot numbers matching those of the stolen product from the market and communicating this action to all authorized distributors and all prescribing physicians, healthcare providers, and patients.

If the stolen product were to be reintroduced into distribution channels, the companies cannot guarantee that products were stored at appropriate temperatures, nor can the companies guarantee the products were not damaged. A voluntary withdrawal of products with lot numbers corresponding to that of the stolen product minimizes the possibility of inadvertent use of stolen product by physicians and, therefore, the overall risk to patients.

On May 7, 2008, JOM discontinued shipment of products with lot numbers matching those of the stolen product. Healthcare providers and patients that did receive product shipped from an authorized distributor on or before this date should consider the product safe for use. Healthcare providers and patients that are concerned about products shipped after this date with the following NDC and lot numbers can return the product by contacting the companies at (888) 626-5660:

NDC Description Lot Number Expiration

Date

59676-3100-1 Cartons containing six (6) D091534 07/2010

single dose vials of

PROCRIT(R) (epoetin alfa)

10,000 U/mL

59676-3200-4 Cartons containing four (4) P113612 09/2010

multidose vials of

PROCRIT(R) (epoetin alfa)

20,000 U/mL

59676-3400-1 Cartons containing four (4) P106803 06/2010

single dose vials of

PROCRIT(R) (epoetin alfa)

40,000 U/mL

17314-9600-1 Cartons containing 1 0717124 03/2009

DOXIL(R) (doxorubicin HCl

liposome injection) 20mg in

10mL (2 mg/mL) single use vial.

17314-9600-2 DOXIL(R) (doxorubicin HCl 0715423 02/2009

liposome injection) 50mg in

25mL (2mg/mL) single use vial

57894-0300-1 Cartons containing one (1) 8AM26021P1 01/2011

vial of REMICADE(R)

(infliximab) 100mg

57894-0300-1 Cartons containing one (1) 8BK35014P1 02/2011

vial of REMICADE(R)

(infliximab) 100mg

No other lot numbers of product are impacted by this incident. All three of these products have tamper-evident features that can be used to authenticate the package. Healthcare professionals and patients who have concerns about any product they possess may contact the number below for assistance with the identification of these features.

The amount of stolen and withdrawn product represents a very small proportion of the total product within the distribution channel; therefore the companies do not anticipate a disruption in product availability for patients.

JOM, Centocor, and Ortho Biotech will continue to work closely with healthcare providers and authorized distribution partners to identify and isolate product with lot numbers corresponding to those of the stolen product, and ask that anyone report any questionable activities to the appropriate authorities. Healthcare professionals, distributors or patients are asked to direct questions related to this voluntary withdrawal to the companies by calling (888) 626-5660.

Please see Important Safety Information for REMICADE(R) (infliximab), PROCRIT(R) (epoetin alfa), and DOXIL(R) (doxorubicin HCl liposome injection) at their respective websites.

About JOM Pharmaceutical Services, Inc.

JOM Pharmaceutical Services, Inc. is a service provider that is dedicated to providing safe and on-time delivery of pharmaceutical products for Ortho Biotech, L.P., Centocor, Inc., and other U.S. pharmaceutical companies.

About Ortho Biotech, L.P.

Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit http://www.orthobiotech.com.

About Centocor, Inc.

Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.


'/>"/>
SOURCE Ortho Biotech, L.P. and Centocor, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Ortho Evra Patch Makers Settling Cases
2. Ortho Biotech Oncology Research & Development Unites Johnson & Johnson Biopharmaceutical Oncology R&D Assets
3. Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa)
4. Osteotech to Present at the Canaccord Adams Small-Cap Orthopedics Conference in San Francisco
5. ROBODOC(R) Emerges as a Curexo Technology Company at Upcoming Orthopaedic Surgeons Conference in San Francisco
6. NuVasive to Present at Canaccord Adams Small-Cap Orthopedics Conference
7. SyntheMed to Present at Canaccord Adams Small-Cap Orthopedics Conference
8. Ortho Biotech Statement On JAMA Publication Regarding Erythropoiesis-Stimulating Agents
9. Symmetry Medical to Present at Canaccord Adams Small-Cap Orthopedics Conference
10. Kensey Nash to Present at the Canaccord Adams Small-Cap Orthopedics Conference
11. Barr and Ortho Womens Health & Urology in Discussions to Settle ORTHO TRI-CYCLEN(R) LO Patent Litigation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/26/2017)... ... July 25, 2017 , ... In this ... understanding of the considerations needed for designing ideal guide RNAs and DNA oligo ... to create targeted double-strand breaks in genomic DNA has greatly simplified strategies for ...
(Date:7/26/2017)... , ... July 26, 2017 , ... ... Research Program at the National Institutes of Health (NIH), will be one of ... annual conference provides a platform for a multi-stakeholder discussion on the latest advancements ...
(Date:7/25/2017)... (PRWEB) , ... July 25, ... ... pleased to welcome Chuck Heinz as Executive Director of Strategic Planning. His ... the Benchworks team. , Chuck’s professional experience encompasses marketing and differentiation consulting, ...
(Date:7/24/2017)... ... July 24, 2017 , ... Each year, Inavero’s Best ... proven their superior service quality as rated by hiring professionals and job candidates. ... based on service quality ratings from their placed talent. , Fewer than 2% ...
Breaking Biology Technology:
(Date:6/14/2017)... IBM ) is introducing several innovative partner startups at VivaTech ... startups and global businesses, taking place in Paris ... will showcase the solutions they have built with IBM Watson ... France is one of the most dynamic ... in the number of startups created between 2012 and 2015*, ...
(Date:5/16/2017)... 16, 2017  Veratad Technologies, LLC ( www.veratad.com ), ... and identity verification solutions, announced today they will participate ... May 15 thru May 17, 2017, in ... Trade Center. Identity impacts the lives ... today,s quickly evolving digital world, defining identity is critical ...
(Date:5/6/2017)... SINGAPORE , May 5, 2017 ... has just announced a new breakthrough in biometric ... that exploits quantum mechanical properties to perform ... new smart semiconductor material created by Ram Group ... across finance, entertainment, transportation, supply chains and security. ...
Breaking Biology News(10 mins):