FOR IMMEDIATE RELEASE - THOUSAND OAKS, Calif. (Sept. 24, 2010) – 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:
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.)
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/ .
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 thirdparty 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.
|
NDC Carton
|
Vial
|
Product Description
|
PROCRIT®
Lot #
|
Expiration
Date
|
|
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
|
FOR IMMEDIATE RELEASE - THOUSAND OAKS, Calif. (Sept. 24, 2010) – 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:
www.fda.gov/MedWatch/getforms.htm .
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:
Cancer:
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.)
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 thirdparty 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:
Lot #
Date
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