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Amgen Initiates Voluntary Nationwide Recall of Certain Lots of EPOGEN® and PROCRIT® (Epoetin alfa)
Date:9/24/2010

THOUSAND OAKS, Calif., Sept. 24 /PRNewswire/ -- Amgen (Nasdaq: AMGN) announced today that certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution.  The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product.  The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy.

Evaluations by Amgen and Centocor Ortho Biotech Products, L.P. found a low potential to impact patients who may have received the affected product.   The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity.  To date, there have been no complaints or adverse events reported which can be directly attributed to the presence of glass lamellae.  

The affected product lot numbers and expiration dates are included in the table below and at www.epogen.com and www.procrit.com.

Adverse events related to EPOGEN should be reported to 1-800-77-AMGEN. Adverse events related to PROCRIT should be reported to 1-800-547-6446. Consumers with questions regarding this recall can contact Amgen at 1-800-77-AMGEN (open 24 hours per day, 7 days per week) or Centocor Ortho Biotech Products at 1-800-547-6446 (open 24 hours per day, 7 days per week).

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.  Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:


  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid FDA form 3500 available at:
    www.fda.gov/MedWatch/getforms.htm.
    Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
  • Fax: 1-800-FDA-0178
  • Amgen and Centocor Ortho Biotech Products and their affiliate companies have initiated recall letters and other communication to immediately inform relevant stakeholders, including healthcare professionals, distributors, wholesalers and pharmacies of the voluntary recall.  The letters include instructions to return the referenced product to the returned goods service provider.

    The recall is being conducted in cooperation with the United States Food and Drug Administration.

    EPOGEN and PROCRIT are manufactured in the United States by Amgen. EPOGEN is sold by Amgen in the United States.  Centocor Ortho Biotech Products is the authorized distributor of PROCRIT in the United States.

    About EPOGEN (Epoetin alfa)EPOGEN is indicated for the treatment of anemia in patients with chronic renal failure on dialysis. EPOGEN is indicated to elevate or maintain the red blood cell (RBC) level and to decrease the need for transfusions in these patients.

    About PROCRIT (Epoetin alfa) PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery.  Depending on the country in which Epoetin alfa is marketed, these indications may differ.

    PROCRIT is licensed from Amgen and manufactured by Amgen in Puerto Rico.

    IMPORTANT SAFETY INFORMATIONWARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE Chronic Renal Failure:

  • In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
  • Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

  • Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (see WARNINGS: Table 1).
  • To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
  • Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense PROCRIT to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
  • Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.

  • Perisurgery: EPOGEN®/PROCRIT® (Epoetin alfa) increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis. (See WARNINGS: Increased Mortality, Serious Cardiovascular Events, Thromboembolic Events, and Stroke, WARNINGS: Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)

  • ESAs are contraindicated in patients with uncontrolled hypertension.

  • About AmgenAmgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit http://www.amgen.com/.

    Forward-Looking StatementsThis news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Sept. 24, 2010 and expressly disclaims any duty to update information contained in this news release.

    No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

    In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

    The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA approved labeling for the products, and not the information discussed in this news release.

    List of EPOGEN lots subject to the voluntary recall:NDC #Lot #Expiration DateNDC 55513-126-10

    EPOGEN®

    1 mL Single-dose, Preservative-free Solution, 2000 Units/mL

    1005282

    03/20111005283

    03/20111006849

    11/20111007312

    09/20111007368

    05/20111009023

    12/20111009398

    12/20111009560

    01/20121011193

    02/20121011194

    03/20121012101

    03/20121012987

    05/20121013876

    07/20121014197

    07/20121014897

    09/20121015495

    10/20121015496

    10/20121016531

    10/20121016646

    12/20111017425

    01/20131017426

    01/20131007967

    05/20111018579

    02/20131018580

    03/20131020267

    04/2013P122524

    02/2011NDC 55513-267-10

    EPOGEN®

    1 mL Single-dose, Preservative-free Solution, 3000 Units/mL

    1005250

    03/20111005265

    04/20111005537

    04/20111005538

    04/20111005829

    05/20111005830

    05/20111006022

    06/20111007326

    10/20111007327

    10/20111007328

    09/20111008418

    11/20111008419

    11/20111008781

    10/20111009045

    12/20111009566

    01/20121009567

    02/20121010430

    12/20111011341

    03/20121011342

    03/20121011344

    03/20121012535

    04/20121012611

    04/20121012612

    05/20121012757

    05/20121013315

    06/20121013870

    07/20121013872

    08/20121014358

    08/20121014899

    09/20121014900

    09/20121015499

    10/20121016651

    12/20121017381

    01/20131017382

    01/20131017472

    01/20131017770

    02/20131017826

    12/20121017891

    12/20121017897

    12/20121018838

    03/20131020182

    05/2013P113704

    09/2010P113707

    10/2010P114930

    10/2010P114931

    10/2010P114932

    11/2010P118857

    12/2010P118859

    03/2011P124804

    03/2011NDC 55513-148-10

    EPOGEN®

    1 mL Single-dose, Preservative-free Solution, 4000 Units/mL

    1005232

    03/20111005233

    03/20111006019

    05/20111006851

    09/20111008416

    10/20111008417

    10/20111008864

    10/20111008962

    10/20111009033

    10/20111009034

    11/20111009035

    11/20111009564

    01/20121009565

    02/20121011176

    02/20121012100

    04/20121012102

    02/20121012810

    05/20121013217

    04/20121013218

    03/20121013360

    06/20121013361

    07/20121014357

    08/20121014901

    09/20121014902

    09/20121016564

    11/20121016647

    12/20121017949

    12/20121018392

    02/20131019006

    03/20131020184

    05/20131021658

    04/2013P114933

    11/2010P114934

    11/2010P120292

    01/2011P120293

    01/2011P122552

    01/2011P122553

    01/2011P122554

    01/2011P122555

    01/2011P122556

    01/2011P122560

    01/2011P122561

    02/2011P122562

    02/2011P122563

    02/2011P122564

    02/2011P122565

    02/2011P122566

    02/2011P122567

    02/2011P122568

    02/2011P122569

    02/2011P122634

    02/2011P122635

    03/2011P123055

    01/2011P123056

    01/2011P123589

    03/2011P127372

    02/2011NDC 55513-144-10

    EPOGEN®

    1 mL Single-dose, Preservative-free Solution, 10,000 Units/mL

    1007320

    11/20111007322

    12/20111009024

    12/20111011174

    02/20121011513

    03/20121014382

    08/20121015286

    08/20121015497

    09/20121015498

    09/20121015704

    10/20121016608

    02/20121018882

    01/20131018883

    02/20131019005

    04/20131019683

    04/2013P113639

    09/2010P113640

    09/2010P113680

    09/2010P113681

    10/2010P113682

    10/2010P113683

    10/2010P113684

    10/2010P114735

    11/2010P114925

    11/2010P114926

    11/2010NDC 55513-283-10

    EPOGEN®

    2 mL Multidose, Preserved Solution, 10,000 Units/mL

    1005267

    03/20111006033

    05/20111007332

    11/20111009047

    11/20111009569

    01/20121011188

    02/20121012007

    03/20121012008

    04/20121012522

    03/20121012523

    03/20121012613

    04/20121012614

    05/20121012758

    05/20121014383

    08/20121016670

    12/2011P113701

    09/2010P113702

    09/2010P122570

    02/2011P124817

    03/2011NDC 55513-478-10

    EPOGEN®

    1 mL Multidose, Preserved Solution, 20,000 Units/mL

    1005268

    04/20111005524

    04/20111005525

    04/20111005526

    04/20111005536

    06/20111006028

    06/20111006029

    06/20111007333

    11/20111007334

    02/20121011196

    02/20121012005

    03/20121012006

    03/20121012536

    04/20121012615

    04/20121012616

    04/20121012617

    04/20121013357

    06/20121014239

    06/20121014361

    08/20121015267

    10/20121015501

    11/20121015795

    09/20121016938

    11/20121017383

    01/2012P113706

    10/2010P122558

    02/2011List of PROCRIT lots subject to the voluntary recall:NDCProduct DescriptionPROCRIT®
    Lot #Expiration
    DateCartonVial59676-302-01

    59676-302-00

    Cartons containing six (6) single-dose vials: 2000 Units/mL

    P122494A

    02/1159676-302-01

    59676-302-00

    Cartons containing six (6) single-dose vials: 2000 Units/mL

    G025790A

    01/1259676-302-01

    59676-302-00

    Cartons containing six (6) single-dose vials: 2000 Units/mL

    G025790C

    01/1259676-302-01

    59676-302-00

    Cartons containing six (6) single-dose vials: 2000 Units/mL

    G025790E

    01/1259676-302-01

    59676-302-00

    Cartons containing six (6) single-dose vials: 2000 Units/mL

    G025790G

    01/1259676-302-01

    59676-302-00

    Cartons containing six (6) single-dose vials: 2000 Units/mL

    G040281A

    10/1259676-302-01

    59676-302-00

    Cartons containing six (6) single-dose vials: 2000 Units/mL

    G040281C

    10/1259676-302-01

    59676-302-00

    Cartons containing six (6) single-dose vials: 2000 Units/mL

    G040281E

    10/1259676-302-01

    59676-302-00

    Cartons containing six (6) single-dose vials: 2000 Units/mL

    G040281G

    10/1259676-302-02

    59676-302-00

    Trays containing twenty-five (25) single-dose vials: 2000 Units/mL

    P122494B

    02/1159676-302-02

    59676-302-00

    Trays containing twenty-five (25) single-dose vials: 2000 Units/mL

    G025790B

    01/1259676-302-02

    59676-302-00

    Trays containing twenty-five (25) single-dose vials: 2000 Units/mL

    G025790D

    01/1259676-302-02

    59676-302-00

    Trays containing twenty-five (25) single-dose vials: 2000 Units/mL

    G025790F

    01/1259676-302-02

    59676-302-00

    Trays containing twenty-five (25) single-dose vials: 2000 Units/mL

    G025790H

    01/1259676-302-02

    59676-302-00

    Trays containing twenty-five (25) single-dose vials: 2000 Units/mL

    G040281B

    10/1259676-302-02

    59676-302-00

    Trays containing twenty-five (25) single-dose vials: 2000 Units/mL

    G040281D

    10/1259676-302-02

    59676-302-00

    Trays containing twenty-five (25) single-dose vials: 2000 Units/mL

    G040281F

    10/1259676-303-01

    59676-303-00

    Cartons containing six (6) single-dose vials: 3000 Units/mL

    P123559A

    02/1159676-303-01

    59676-303-00

    Cartons containing six (6) single-dose vials: 3000 Units/mL

    P123559C

    02/1159676-303-01

    59676-303-00

    Cartons containing six (6) single-dose vials: 3000 Units/mL

    P123559E

    02/1159676-303-01

    59676-303-00

    Cartons containing six (6) single-dose vials: 3000 Units/mL

    P123559G

    02/1159676-303-01

    59676-303-00

    Cartons containing six (6) single-dose vials: 3000 Units/mL

    P123559J

    02/1159676-303-01

    59676-303-00

    Cartons containing six (6) single-dose vials: 3000 Units/mL

    G034141A

    07/1259676-303-01

    59676-303-00

    Cartons containing six (6) single-dose vials: 3000 Units/mL

    G034141C

    07/1259676-303-01

    59676-303-00

    Cartons containing six (6) single-dose vials: 3000 Units/mL

    G034141E

    07/1259676-303-01

    59676-303-00

    Cartons containing six (6) single-dose vials: 3000 Units/mL

    G034141G

    07/1259676-303-01

    59676-303-00

    Cartons containing six (6) single-dose vials: 3000 Units/mL

    G034141I

    07/1259676-303-02

    59676-303-00

    Trays containing twenty-five (25) single-dose vials: 3000 Units/mL

    P123559B

    02/1159676-303-02

    59676-303-00

    Trays containing twenty-five (25) single-dose vials: 3000 Units/mL

    P123559D

    02/1159676-303-02

    59676-303-00

    Trays containing twenty-five (25) single-dose vials: 3000 Units/mL

    P123559F

    02/1159676-303-02

    59676-303-00

    Trays containing twenty-five (25) single-dose vials: 3000 Units/mL

    P123559H

    02/1159676-303-02

    59676-303-00

    Trays containing twenty-five (25) single-dose vials: 3000 Units/mL

    P123559I

    02/1159676-303-02

    59676-303-00

    Trays containing twenty-five (25) single-dose vials: 3000 Units/mL

    G034141B

    07/1259676-303-02

    59676-303-00

    Trays containing twenty-five (25) single-dose vials: 3000 Units/mL

    G034141D

    07/1259676-303-02

    59676-303-00

    Trays containing twenty-five (25) single-dose vials: 3000 Units/mL

    G034141F

    07/1259676-303-02

    59676-303-00

    Trays containing twenty-five (25) single-dose vials: 3000 Units/mL

    G034141H

    07/1259676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    P114937A

    10/1059676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    P114937B

    10/1059676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    P114937D

    10/1059676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    P114937E

    10/1059676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    P114937G

    10/1059676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    G008097A

    05/1159676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    G008097D

    05/1159676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    G008097E

    05/1159676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    G008097H

    05/1159676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    G008097I

    05/1159676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    G044999A

    12/1259676-304-01

    59676-304-00

    Cartons containing six (6) single-dose vials: 4000 Units/mL

    G044999C

    12/1259676-304-02

    59676-304-00

    Trays containing twenty-five (25) single-dose vials: 4000 Units/mL

    P114937A

    10/1059676-304-02

    59676-304-00

    Trays containing twenty-five (25) single-dose vials: 4000 Units/mL

    P114937C

    10/1059676-304-02

    59676-304-00

    Trays containing twenty-five (25) single-dose vials: 4000 Units/mL

    P114937F

    10/1059676-304-02

    59676-304-00

    Trays containing twenty-five (25) single-dose vials: 4000 Units/mL

    P114937H

    10/1059676-304-02

    59676-304-00

    Trays containing twenty-five (25) single-dose vials: 4000 Units/mL

    G008097B

    05/1159676-304-02

    59676-304-00

    Trays containing twenty-five (25) single-dose vials: 4000 Units/mL

    G008097C

    05/1159676-304-02

    59676-304-00

    Trays containing twenty-five (25) single-dose vials: 4000 Units/mL

    G008097F

    05/1159676-304-02

    59676-304-00

    Trays containing twenty-five (25) single-dose vials: 4000 Units/mL

    G008097G

    05/1159676-304-02

    59676-304-00

    Trays containing twenty-five (25) single-dose vials: 4000 Units/mL

    G008097J

    05/1159676-304-02

    59676-304-00

    Trays containing twenty-five (25) single-dose vials: 4000 Units/mL

    G044999B

    12/1259676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D091535A

    08/1059676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D091537A

    09/1059676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D091543A

    11/1059676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D121435A

    01/1159676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D121438A

    04/1159676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D121440A

    04/1159676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D121442A

    08/1159676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D121443A

    08/1159676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D121446A

    09/1159676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D121448A

    10/1159676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D121450A

    10/1159676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    D121452A

    11/1159676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    G022047A

    11/1159676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    G022046A

    01/1259676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    G024089A

    01/1259676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    G030138A

    03/1259676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    G030139A

    04/1259676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    G049114A

    01/1359676-310-01

    59676-310-00

    Cartons containing six (6) single-dose vials: 10,000 Units/mL

    G063222A

    06/1359676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D091536A

    08/1059676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D091538A

    09/1059676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D091540A

    11/1059676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D091540B

    11/1059676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121436A

    02/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121437A

    03/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121439A

    04/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121441A

    08/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121444A

    08/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121445A

    09/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121447A

    10/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121449A

    10/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121451A

    11/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121453A

    11/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121454A

    11/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    D121455A

    11/1159676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    G024090A

    02/1259676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    G024091A

    02/1259676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    G024092B

    03/1259676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    G030140A

    04/1259676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    G041814A

    10/1259676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    G049114B

    01/1359676-310-02

    59676-310-00

    Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL

    G063222B

    06/1359676-312-04

    59676-312-00

    2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL

    P114942A

    12/1059676-312-04

    59676-312-00

    2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL

    G013948A

    06/1159676-312-04

    59676-312-00

    2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL

    G025126A

    03/1259676-312-04

    59676-312-00

    2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL

    G025126B

    03/1259676-312-04

    59676-312-00

    2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL

    G025126C

    03/1259676-312-04

    59676-312-00

    2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL

    G025126D

    03/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    P113612

    09/1059676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    P114943A

    11/1059676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    P114944A

    12/1059676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    P118909A

    01/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    P118909B

    01/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    P120287A

    03/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    P120287B

    03/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G004579A

    04/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G004581A

    04/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G008101A

    05/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G008102A

    06/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G008102B

    06/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G019661A

    11/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G019713A

    12/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G019713B

    12/1159676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G019989A

    02/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G025158A

    03/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G025158B

    03/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G030321A

    05/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G030321B

    05/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G038150A

    09/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G038150B

    09/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G038150C

    09/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G040574A

    10/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G040574B

    10/1259676-320-04

    59676-320-00

    1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL

    G043195A

    12/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    P114920A

    11/1059676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    P114920B

    11/1059676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    P114946A

    01/1159676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    P114947A

    02/1159676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G004598A

    05/1159676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G008109A

    06/1159676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G008109B

    06/1159676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G022657A

    01/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G022657B

    01/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G019991A

    02/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G019991B

    02/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G024766A

    03/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G024766B

    03/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G031993A

    05/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G031993B

    05/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G031993C

    05/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G031993D

    05/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G038151A

    09/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G038151B

    09/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G045000A

    12/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G045000B

    12/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G047779A

    12/1259676-340-01

    59676-340-00

    Cartons containing four (4) single-dose vials: 40,000 Units/mL

    G049110A

    02/13CONTACT: Amgen:Emma Hurley (media): 202-585-9647 Arvind Sood (investors): 805-447-1060 Centocor Ortho Biotech Products, L.P.:Lisa Vaga (media): 908-218-7316 / 908-670-0363 (Cell)(Logo:  http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

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