Amgen Recalls Specific Lots of Epogen and Procrit Due to Glass Flakes

Are you a veterinarian using IVIG for immune-mediated thrombocytopenia? Amgen recalls certain lots of Epogen and Procrit. See lot numbers below.

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.com9 and www.procrit.com10.

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.com13 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/14.

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:

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

 

Published: September 27, 2010;    Updated: September 27, 2010

Filed Under: Recalls Warnings

Author: Oregon Veterinary Medical Association

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