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
multi

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