Amgen Initiates Voluntary Nationwide Recall of Certain Lots of EPOGEN® and PROCRIT® (Epoetin alfa)

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Sep 24, 2010, 09:09 ET

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 INFORMATION

WARNINGS: 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 Amgen

Amgen 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 Statements

This 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 Date
NDC 55513-126-10 EPOGEN® 1 mL Single-dose, Preservative-free Solution, 2000 Units/mL	1005282	03/2011
	1005283	03/2011
	1006849	11/2011
	1007312	09/2011
	1007368	05/2011
	1009023	12/2011
	1009398	12/2011
	1009560	01/2012
	1011193	02/2012
	1011194	03/2012
	1012101	03/2012
	1012987	05/2012
	1013876	07/2012
	1014197	07/2012
	1014897	09/2012
	1015495	10/2012
	1015496	10/2012
	1016531	10/2012
	1016646	12/2011
	1017425	01/2013
	1017426	01/2013
	1007967	05/2011
	1018579	02/2013
	1018580	03/2013
	1020267	04/2013
	P122524	02/2011
NDC 55513-267-10 EPOGEN® 1 mL Single-dose, Preservative-free Solution, 3000 Units/mL	1005250	03/2011
	1005265	04/2011
	1005537	04/2011
	1005538	04/2011
	1005829	05/2011
	1005830	05/2011
	1006022	06/2011
	1007326	10/2011
	1007327	10/2011
	1007328	09/2011
	1008418	11/2011
	1008419	11/2011
	1008781	10/2011
	1009045	12/2011
	1009566	01/2012
	1009567	02/2012
	1010430	12/2011
	1011341	03/2012
	1011342	03/2012
	1011344	03/2012
	1012535	04/2012
	1012611	04/2012
	1012612	05/2012
	1012757	05/2012
	1013315	06/2012
	1013870	07/2012
	1013872	08/2012
	1014358	08/2012
	1014899	09/2012
	1014900	09/2012
	1015499	10/2012
	1016651	12/2012
	1017381	01/2013
	1017382	01/2013
	1017472	01/2013
	1017770	02/2013
	1017826	12/2012
	1017891	12/2012
	1017897	12/2012
	1018838	03/2013
	1020182	05/2013
	P113704	09/2010
	P113707	10/2010
	P114930	10/2010
	P114931	10/2010
	P114932	11/2010
	P118857	12/2010
	P118859	03/2011
	P124804	03/2011
NDC 55513-148-10 EPOGEN® 1 mL Single-dose, Preservative-free Solution, 4000 Units/mL	1005232	03/2011
	1005233	03/2011
	1006019	05/2011
	1006851	09/2011
	1008416	10/2011
	1008417	10/2011
	1008864	10/2011
	1008962	10/2011
	1009033	10/2011
	1009034	11/2011
	1009035	11/2011
	1009564	01/2012
	1009565	02/2012
	1011176	02/2012
	1012100	04/2012
	1012102	02/2012
	1012810	05/2012
	1013217	04/2012
	1013218	03/2012
	1013360	06/2012
	1013361	07/2012
	1014357	08/2012
	1014901	09/2012
	1014902	09/2012
	1016564	11/2012
	1016647	12/2012
	1017949	12/2012
	1018392	02/2013
	1019006	03/2013
	1020184	05/2013
	1021658	04/2013
	P114933	11/2010
	P114934	11/2010
	P120292	01/2011
	P120293	01/2011
	P122552	01/2011
	P122553	01/2011
	P122554	01/2011
	P122555	01/2011
	P122556	01/2011
	P122560	01/2011
	P122561	02/2011
	P122562	02/2011
	P122563	02/2011
	P122564	02/2011
	P122565	02/2011
	P122566	02/2011
	P122567	02/2011
	P122568	02/2011
	P122569	02/2011
	P122634	02/2011
	P122635	03/2011
	P123055	01/2011
	P123056	01/2011
	P123589	03/2011
	P127372	02/2011
NDC 55513-144-10 EPOGEN® 1 mL Single-dose, Preservative-free Solution, 10,000 Units/mL	1007320	11/2011
	1007322	12/2011
	1009024	12/2011
	1011174	02/2012
	1011513	03/2012
	1014382	08/2012
	1015286	08/2012
	1015497	09/2012
	1015498	09/2012
	1015704	10/2012
	1016608	02/2012
	1018882	01/2013
	1018883	02/2013
	1019005	04/2013
	1019683	04/2013
	P113639	09/2010
	P113640	09/2010
	P113680	09/2010
	P113681	10/2010
	P113682	10/2010
	P113683	10/2010
	P113684	10/2010
	P114735	11/2010
	P114925	11/2010
	P114926	11/2010
NDC 55513-283-10 EPOGEN® 2 mL Multidose, Preserved Solution, 10,000 Units/mL	1005267	03/2011
	1006033	05/2011
	1007332	11/2011
	1009047	11/2011
	1009569	01/2012
	1011188	02/2012
	1012007	03/2012
	1012008	04/2012
	1012522	03/2012
	1012523	03/2012
	1012613	04/2012
	1012614	05/2012
	1012758	05/2012
	1014383	08/2012
	1016670	12/2011
	P113701	09/2010
	P113702	09/2010
	P122570	02/2011
	P124817	03/2011
NDC 55513-478-10 EPOGEN® 1 mL Multidose, Preserved Solution, 20,000 Units/mL	1005268	04/2011
	1005524	04/2011
	1005525	04/2011
	1005526	04/2011
	1005536	06/2011
	1006028	06/2011
	1006029	06/2011
	1007333	11/2011
	1007334	02/2012
	1011196	02/2012
	1012005	03/2012
	1012006	03/2012
	1012536	04/2012
	1012615	04/2012
	1012616	04/2012
	1012617	04/2012
	1013357	06/2012
	1014239	06/2012
	1014361	08/2012
	1015267	10/2012
	1015501	11/2012
	1015795	09/2012
	1016938	11/2012
	1017383	01/2012
	P113706	10/2010
	P122558	02/2011

List of PROCRIT lots subject to the voluntary recall:


NDC		Product Description	PROCRIT® Lot #	Expiration Date
Carton	Vial
59676-302-01	59676-302-00	Cartons containing six (6) single-dose vials: 2000 Units/mL	P122494A	02/11
59676-302-01	59676-302-00	Cartons containing six (6) single-dose vials: 2000 Units/mL	G025790A	01/12
59676-302-01	59676-302-00	Cartons containing six (6) single-dose vials: 2000 Units/mL	G025790C	01/12
59676-302-01	59676-302-00	Cartons containing six (6) single-dose vials: 2000 Units/mL	G025790E	01/12
59676-302-01	59676-302-00	Cartons containing six (6) single-dose vials: 2000 Units/mL	G025790G	01/12
59676-302-01	59676-302-00	Cartons containing six (6) single-dose vials: 2000 Units/mL	G040281A	10/12
59676-302-01	59676-302-00	Cartons containing six (6) single-dose vials: 2000 Units/mL	G040281C	10/12
59676-302-01	59676-302-00	Cartons containing six (6) single-dose vials: 2000 Units/mL	G040281E	10/12
59676-302-01	59676-302-00	Cartons containing six (6) single-dose vials: 2000 Units/mL	G040281G	10/12
59676-302-02	59676-302-00	Trays containing twenty-five (25) single-dose vials: 2000 Units/mL	P122494B	02/11
59676-302-02	59676-302-00	Trays containing twenty-five (25) single-dose vials: 2000 Units/mL	G025790B	01/12
59676-302-02	59676-302-00	Trays containing twenty-five (25) single-dose vials: 2000 Units/mL	G025790D	01/12
59676-302-02	59676-302-00	Trays containing twenty-five (25) single-dose vials: 2000 Units/mL	G025790F	01/12
59676-302-02	59676-302-00	Trays containing twenty-five (25) single-dose vials: 2000 Units/mL	G025790H	01/12
59676-302-02	59676-302-00	Trays containing twenty-five (25) single-dose vials: 2000 Units/mL	G040281B	10/12
59676-302-02	59676-302-00	Trays containing twenty-five (25) single-dose vials: 2000 Units/mL	G040281D	10/12
59676-302-02	59676-302-00	Trays containing twenty-five (25) single-dose vials: 2000 Units/mL	G040281F	10/12
59676-303-01	59676-303-00	Cartons containing six (6) single-dose vials: 3000 Units/mL	P123559A	02/11
59676-303-01	59676-303-00	Cartons containing six (6) single-dose vials: 3000 Units/mL	P123559C	02/11
59676-303-01	59676-303-00	Cartons containing six (6) single-dose vials: 3000 Units/mL	P123559E	02/11
59676-303-01	59676-303-00	Cartons containing six (6) single-dose vials: 3000 Units/mL	P123559G	02/11
59676-303-01	59676-303-00	Cartons containing six (6) single-dose vials: 3000 Units/mL	P123559J	02/11
59676-303-01	59676-303-00	Cartons containing six (6) single-dose vials: 3000 Units/mL	G034141A	07/12
59676-303-01	59676-303-00	Cartons containing six (6) single-dose vials: 3000 Units/mL	G034141C	07/12
59676-303-01	59676-303-00	Cartons containing six (6) single-dose vials: 3000 Units/mL	G034141E	07/12
59676-303-01	59676-303-00	Cartons containing six (6) single-dose vials: 3000 Units/mL	G034141G	07/12
59676-303-01	59676-303-00	Cartons containing six (6) single-dose vials: 3000 Units/mL	G034141I	07/12
59676-303-02	59676-303-00	Trays containing twenty-five (25) single-dose vials: 3000 Units/mL	P123559B	02/11
59676-303-02	59676-303-00	Trays containing twenty-five (25) single-dose vials: 3000 Units/mL	P123559D	02/11
59676-303-02	59676-303-00	Trays containing twenty-five (25) single-dose vials: 3000 Units/mL	P123559F	02/11
59676-303-02	59676-303-00	Trays containing twenty-five (25) single-dose vials: 3000 Units/mL	P123559H	02/11
59676-303-02	59676-303-00	Trays containing twenty-five (25) single-dose vials: 3000 Units/mL	P123559I	02/11
59676-303-02	59676-303-00	Trays containing twenty-five (25) single-dose vials: 3000 Units/mL	G034141B	07/12
59676-303-02	59676-303-00	Trays containing twenty-five (25) single-dose vials: 3000 Units/mL	G034141D	07/12
59676-303-02	59676-303-00	Trays containing twenty-five (25) single-dose vials: 3000 Units/mL	G034141F	07/12
59676-303-02	59676-303-00	Trays containing twenty-five (25) single-dose vials: 3000 Units/mL	G034141H	07/12
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	P114937A	10/10
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	P114937B	10/10
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	P114937D	10/10
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	P114937E	10/10
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	P114937G	10/10
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	G008097A	05/11
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	G008097D	05/11
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	G008097E	05/11
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	G008097H	05/11
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	G008097I	05/11
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	G044999A	12/12
59676-304-01	59676-304-00	Cartons containing six (6) single-dose vials: 4000 Units/mL	G044999C	12/12
59676-304-02	59676-304-00	Trays containing twenty-five (25) single-dose vials: 4000 Units/mL	P114937A	10/10
59676-304-02	59676-304-00	Trays containing twenty-five (25) single-dose vials: 4000 Units/mL	P114937C	10/10
59676-304-02	59676-304-00	Trays containing twenty-five (25) single-dose vials: 4000 Units/mL	P114937F	10/10
59676-304-02	59676-304-00	Trays containing twenty-five (25) single-dose vials: 4000 Units/mL	P114937H	10/10
59676-304-02	59676-304-00	Trays containing twenty-five (25) single-dose vials: 4000 Units/mL	G008097B	05/11
59676-304-02	59676-304-00	Trays containing twenty-five (25) single-dose vials: 4000 Units/mL	G008097C	05/11
59676-304-02	59676-304-00	Trays containing twenty-five (25) single-dose vials: 4000 Units/mL	G008097F	05/11
59676-304-02	59676-304-00	Trays containing twenty-five (25) single-dose vials: 4000 Units/mL	G008097G	05/11
59676-304-02	59676-304-00	Trays containing twenty-five (25) single-dose vials: 4000 Units/mL	G008097J	05/11
59676-304-02	59676-304-00	Trays containing twenty-five (25) single-dose vials: 4000 Units/mL	G044999B	12/12
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D091535A	08/10
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D091537A	09/10
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D091543A	11/10
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D121435A	01/11
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D121438A	04/11
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D121440A	04/11
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D121442A	08/11
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D121443A	08/11
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D121446A	09/11
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D121448A	10/11
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D121450A	10/11
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	D121452A	11/11
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	G022047A	11/11
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	G022046A	01/12
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	G024089A	01/12
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	G030138A	03/12
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	G030139A	04/12
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	G049114A	01/13
59676-310-01	59676-310-00	Cartons containing six (6) single-dose vials: 10,000 Units/mL	G063222A	06/13
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D091536A	08/10
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D091538A	09/10
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D091540A	11/10
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D091540B	11/10
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121436A	02/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121437A	03/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121439A	04/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121441A	08/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121444A	08/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121445A	09/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121447A	10/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121449A	10/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121451A	11/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121453A	11/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121454A	11/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	D121455A	11/11
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	G024090A	02/12
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	G024091A	02/12
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	G024092B	03/12
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	G030140A	04/12
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	G041814A	10/12
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	G049114B	01/13
59676-310-02	59676-310-00	Trays containing twenty-five (25) single-dose vials: 10,000 Units/mL	G063222B	06/13
59676-312-04	59676-312-00	2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL	P114942A	12/10
59676-312-04	59676-312-00	2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL	G013948A	06/11
59676-312-04	59676-312-00	2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL	G025126A	03/12
59676-312-04	59676-312-00	2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL	G025126B	03/12
59676-312-04	59676-312-00	2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL	G025126C	03/12
59676-312-04	59676-312-00	2 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 10,000 Units/mL	G025126D	03/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	P113612	09/10
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	P114943A	11/10
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	P114944A	12/10
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	P118909A	01/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	P118909B	01/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	P120287A	03/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	P120287B	03/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G004579A	04/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G004581A	04/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G008101A	05/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G008102A	06/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G008102B	06/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G019661A	11/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G019713A	12/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G019713B	12/11
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G019989A	02/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G025158A	03/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G025158B	03/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G030321A	05/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G030321B	05/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G038150A	09/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G038150B	09/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G038150C	09/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G040574A	10/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G040574B	10/12
59676-320-04	59676-320-00	1 mL Multidose, Preserved Solution Cartons containing four (4) multidose vials: 20,000 Units/mL	G043195A	12/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	P114920A	11/10
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	P114920B	11/10
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	P114946A	01/11
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	P114947A	02/11
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G004598A	05/11
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G008109A	06/11
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G008109B	06/11
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G022657A	01/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G022657B	01/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G019991A	02/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G019991B	02/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G024766A	03/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G024766B	03/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G031993A	05/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G031993B	05/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G031993C	05/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G031993D	05/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G038151A	09/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G038151B	09/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G045000A	12/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G045000B	12/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G047779A	12/12
59676-340-01	59676-340-00	Cartons containing four (4) single-dose vials: 40,000 Units/mL	G049110A	02/13

CONTACT:
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)