Navigation Links
American Regent, Inc. Initiates Voluntary Recall of Seventeen Lots of Vasopressin Injection, USP, Multiple Dose Vials due to Sub-Potency
Date:8/3/2011

SHIRLEY, N.Y., Aug. 3, 2011 /PRNewswire/ -- American Regent, Inc. is conducting a nationwide voluntary recall of 5 lots of Vasopressin Injection, USP 20 units/mL (200 units/10 mL), 10 mL Multiple Dose Vials; 11 lots of Vasopressin Injection, USP 20 units/mL, 1 mL Multiple Dose Vials; and 1 lot of Vasopressin Injection, USP 10 units/0.5 mL, 0.5 mL Multiple Dose Vials to the Retail/Hospital level. Recall of this product was initiated by American Regent, Inc. because some vials may not maintain potency throughout their shelf-life.

Potential adverse events after administration of solutions that are below potency limits may include reduced effectiveness.  American Regent, Inc. has received no reports of adverse events related to reduced effectiveness for Vasopressin Injection, USP of the lots being recalled during the time period January 1, 2009 to July 27, 2011.  

Vasopressin Injection, USP is indicated for prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel interfering gas shadows, and in diabetes insipidus.

Below are the product sizes and lots affected.  The product was distributed to wholesalers and distributors nationwide.Vasopressin Injection, USP 20 units/mL (200 units/10 mL), 10 mL multiple dose vial,Package Size:  10, NDC # 0517-0410-10Lot #Exp DateExp Period9677

October 2011

24 months0052

January 2012

24 months0294

October 2011

18 months0442

December 2011

18 months0663

April 2012

18 monthsVasopressin Injection, USP 20 units/mL, 1 mL multiple dose vial, Package Size:  25,NDC # 0517-1020-25Lot #Exp DateExp Period9532

August 2011

24 months9618

September 2011

24 months9707

October 2011

24 months0104

February 2012

24 months0124

February 2012

24 months0273

October 2011

18 months0346

November 2011

18 months0400

December 2011

18 months0437

December 2011

18 months0618

March 2012

18 months0758

May 2012

18 monthsVasopressin Injection, USP 10 units/0.5 mL, 0.5 mL multiple dose vialPackage Size:  25, NDC # 0517-0510-25  Lot #Exp DateExp Period0103

February 2012

24 monthsHospitals, infusion centers, clinics, retail pharmacies and other healthcare facilities should not use American Regent, Inc., Vasopressin Injection, USP Multiple Dose Vials with the lot #s listed above for patient care and should immediately quarantine any product for return to American Regent Inc.

American Regent, Inc. will credit accounts for all returned product with these lot #s. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30 AM to 7:00 PM EDT. Hospitals, infusion centers, clinics, retail pharmacies and other healthcare facilities with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232: Monday thru Friday from 9:00 AM to 5:00 PM EDT. Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via e-mail at luitpold.com,">pv@luitpold.com, by fax to (610) 650-0170, or by phone at 1-800-734-9236: Monday thru Friday from 9:00 AM to 5:00 PM EDT. TO EXPEDITE HANDLING, PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS E-MAIL ADDRESS OR FAX OR PHONE. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax.

  • Online: www.fda.gov/medwatch/report.htm

  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

  • Fax: 1-800-FDA-0178.

  • This voluntary recall is being conducted with the knowledge of the U.S. Food & Drug Administration.

    Vasopressin Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).


    '/>"/>

    SOURCE Luitpold Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
    2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
    3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
    4. Aspirin Named 8th World Wonder by Majority of Americans
    5. MedImmunes Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
    6. American Heart Association Comment Saving Lives in Type 2 Diabetics: Could It Be as Easy as Lowering Blood Pressure?
    7. TrialCheck(R) Cancer Clinical Trial Matching Interface to Debut on American Cancer Society Web Site
    8. Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics Hypertension Better Controlled With Equal Access to Care
    9. Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting
    10. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
    11. New MIRCERA(R) Data Analyses to be Featured at the American Society of Nephrology Annual Meeting
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
    (Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it ... (procalcitonin) assay as a dedicated testing solution for people ... Roche is the first IVD company in the U.S ... assessment and management. PCT is a sepsis-specific ... blood can aid clinicians in assessing the risk of ...
    (Date:6/23/2016)... MOUNTAIN VIEW, Calif. , June 23, 2016 ... 9:00 a.m. CST on Thursday, July 7, 2016 , , ... kayla.belcher@frost.com ) , , , , EXPERT PANELISTS:  ... Sciences, Nitin Naik; Senior Industry Analyst, Christi Bird; Senior Industry Analyst, ... The global pharmaceutical industry is witnessing ...
    Breaking Medicine Technology:
    (Date:6/25/2016)... Oklahoma (PRWEB) , ... June 25, 2016 , ... ... both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures ... Oklahoma City area —Johnson is one of the first doctors to perform the ...
    (Date:6/25/2016)... Montreal, Canada (PRWEB) , ... June 25, 2016 , ... ... the pursuit of success. In terms of the latter, setting the bar too high ... low, risk more than just slow progress toward their goal. , Research from ...
    (Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Those who ... with these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, ... Marne, Michigan, has released tools for healthy coping following a traumatic event. , Trauma ...
    (Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
    (Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
    Breaking Medicine News(10 mins):