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The amount of PROCRIT being withdrawn represents a very small proportion of the total product within the distribution channel; therefore the company does not anticipate a disruption in product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:10/10/2017)... ... October 10, 2017 , ... San Diego-based team building ... corporate rebranding initiative announced today. The bold new look is part of a ... company moves into a significant growth period. , It will also expand its service ...
(Date:10/10/2017)... , Oct. 10, 2017 SomaGenics announced ... the NIH to develop RealSeq®-SC (Single Cell), expected to ... profiling small RNAs (including microRNAs) from single cells using ... highlights the need to accelerate development of approaches to ... "New techniques for measuring levels of ...
(Date:10/9/2017)... ... October 09, 2017 , ... At its national board meeting in ... professor in Harvard University’s Departments of Physics and Astronomy, has been selected for membership ... the winning team for the 2015 Breakthrough Prize in Fundamental physics for the discovery ...
(Date:10/7/2017)... 2017  The 2017 Nobel Prize in Chemistry ... Dubochet, Joachim Frank and Richard ... microscopy (cryo-EM) have helped to broaden the ... community. The winners worked with systems manufactured by ... highly resolved, three-dimensional images of protein structures that ...
Breaking Biology Technology:
(Date:4/13/2017)... 2017 UBM,s Advanced Design and Manufacturing event ... emerging and evolving technology through its 3D Printing and ... alongside the expo portion of the event and feature ... focused on trending topics within 3D printing and smart ... event will take place June 13-15, 2017 at the Jacob ...
(Date:4/11/2017)... BEACH GARDENS, Fla. , April 11, 2017 ... identity management and secure authentication solutions, today announced ... contract by Intelligence Advanced Research Projects Activity (IARPA) ... for IARPA,s Thor program. "Innovation has ... onset and IARPA,s Thor program will allow us ...
(Date:4/11/2017)... 11, 2017 No two people are ... the New York University Tandon School of Engineering ... found that partial similarities between prints are common ... mobile phones and other electronic devices can be ... vulnerability lies in the fact that fingerprint-based authentication ...
Breaking Biology News(10 mins):