Navigation Links
Ortho Biotech Announces Nationwide Voluntary Recall of Procrit(R) (Epoetin Alfa) Lot Number P114942A
Date:8/5/2008

BRIDGEWATER, N.J., Aug. 5 /PRNewswire/ -- Ortho Biotech is announcing that it is voluntarily recalling one manufacturing lot (P114942A) of PROCRIT(R) (Epoetin alfa) after having identified cracks in the necks of a small number of vials upon post-manufacturing inspection. No other lot of this product is affected by this recall. Approximately 44,292 vials of lot P114942A in the following packaging configurations were distributed between April 15, 2008 and July 17, 2008.

NDC Description Lot Expiration

Number Date

59676-312-00 Individual multi-dose vials

of PROCRIT(R) (Epoetin alfa) P114942A 12/10

10,000 U/2mL

59676-312-04 Cartons containing 4

multi-dose vials of PROCRIT(R) P114942A 12/10

(Epoetin alfa) 10,000 U/2mL

Vials exhibiting even slight cracks may not maintain their sterile condition and should not be used for subcutaneous or intravenous injection.

To ensure patient safety, Ortho Biotech is voluntarily recalling PROCRIT vials from this manufacturing lot only. Ortho Biotech is notifying the authorized distributors, prescribing physicians and patients of this recall. The recall is being conducted in cooperation with the U.S. Food and Drug Administration.

PROCRIT from manufacturing lots other than the above, shipped from an authorized distributor is not being recalled.

PROCRIT vials from the above recalled lot should be promptly returned by contacting the returned goods service provider, at (800) 668-4391.

Healthcare providers and patients with questions about this recall notice can contact the Ortho Biotech Medical Information Department at (888) 227-5624, Monday through Friday, 8:30 am to 5:00 pm EDT.

The amount of PROCRIT being withdrawn represents a very small proportion of the total product within the distribution channel; therefore the company does not anticipate a disruption in product availability for patients.

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.


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

Related biology technology :

1. Ortho Biotech Supports FDA Advisory Committees Recommendations on Use of ESAs in Chronic Renal Failure Patients
2. Isis Enters Broad Collaboration With Ortho-McNeil, Inc. for the Discovery, Development and Commercialization of Antisense Drugs to Treat Metabolic Diseases
3. New Orthopedic Surgical Robotics Company Opens Its Doors; Files with the FDA for Clearance of Its Flagship Product
4. Innovative Neurotronics, a Subsidiary of Hanger Orthopedic Group, Earns the 2007 da Vinci Award for the WalkAide System
5. Bone-growing nanomaterial could improve orthopaedic implants
6. Advancements in Population Age and Technology Drive Future of Orthopedic Materials Market
7. Collagen Matrix, Inc. Launches OssiMend(TM) Bone Graft Matrix for Orthopedic and Spine Applications
8. Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa) Label Reflects Recommendations from Recent FDA Advisory Committee Meetings
9. Progentix Orthobiology B.V. Closes Series A Financing Round
10. Barr and Ortho Womens Health & Urology in Discussions to Settle ORTHO TRI-CYCLEN(R) LO Patent Litigation
11. Kensey Nash to Present at the Canaccord Adams Small-Cap Orthopedics Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/11/2017)... ... 2017 , ... As a graduate student, Scarlet Shell spent ... cause malaria and tuberculosis. Seeing firsthand the ravages those diseases visit on vulnerable ... assistant professor of biology and biotechnology at Worcester Polytechnic Institute (WPI), Shell has ...
(Date:1/11/2017)... Linda, Ca (PRWEB) , ... January 11, 2017 ... ... the U.S. each year and costing healthcare systems more than $23.7 billion, ... while controlling costs. , Among the most common sepsis-causing pathogens are bacteria ...
(Date:1/11/2017)... ... January 11, 2017 , ... IsoPlexis Corporation ... analysis platform to measure the proteomic function of individual cells in patients, today ... (SBIR) grant from the National Institute on Aging of the National Institutes of ...
(Date:1/11/2017)... Rockwall Texas (PRWEB) , ... January 11, 2017 , ... ... Clinics. No Drugs, No Shots and No Surgery for positive back pain relief for ... 150,000 documented positive results worldwide and could be life changing for millions suffering from ...
Breaking Biology Technology:
(Date:1/6/2017)... 5, 2017  Delta ID Inc., a leader in ... for automotive at CES® 2017. Delta ID has collaborated ... demonstrate the use of iris scanning as a secure, ... driver in a car, and as a way to ... Delta ID and Gentex will demonstrate (booth ...
(Date:1/3/2017)... , Jan. 3, 2017 Onitor, provider of ... of Onitor Track, an innovative biometric data-driven program designed ... this month at the 2017 Consumer Electronics Show (CES) ... In the U.S., the World Health Organization (WHO), ... two-thirds of adults who are overweight or obese. WHO ...
(Date:12/20/2016)... -- The rising popularity of mobility services such ... significant interest in keyless access systems. Following the ... (BLE), biometrics and near-field communication (NFC) are poised ... technologies in the automotive industry. This evolution from ... opens the market to specialist companies such as ...
Breaking Biology News(10 mins):