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

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,">, 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:

  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: 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:
    (Date:6/23/2016)... , June 23, 2016 Any dentist who ... challenges of the current process. Many of them do not ... the technical difficulties and high laboratory costs involved. And those ... offer it at such a high cost that the majority ... Dr. Parsa Zadeh , founder of Dental ...
    (Date:6/23/2016)... June 23, 2016 Roche (SIX: RO, ROG; ... for its Elecsys BRAHMS PCT (procalcitonin) assay as a ... septic shock. With this clearance, Roche is the first ... integrated solution for sepsis risk assessment and management. ... infection and PCT levels in blood can aid clinicians ...
    (Date:6/23/2016)... , June 23, 2016 Research ... Pharma News Issue 52" report to their offering. ... in influenza treatment creates a favourable commercial environment for MedImmune ... growing patient base that will serve to drive considerable growth ... vaccine would serve to cap sales considerably, but development is ...
    Breaking Medicine Technology:
    (Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
    (Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, ... Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms ... Final Cut Pro X . Simply select a ProHand generator and drag it above ...
    (Date:6/25/2016)... ... June 25, 2016 , ... Dr. ... from injury. Recently, he has implemented orthobiologic procedures as a method for treating ... one of the first doctors to perform the treatment. Orthobiologics are substances that ...
    (Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
    (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 ...
    Breaking Medicine News(10 mins):