Vasopressin Injection Recalled Over Potency Issue

American Regent, Inc. is issuing a recall of some lots of Vasopressin over potency issues, the U.S. Food and Drug Administration (FDA) just announced.

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.

Potential adverse events after administration of the recalled solutions over potency issues could involve reduction in the medication’s efficacy. To date, American Regent, Inc. has not received any reports of adverse events related to reduced efficacy for the defective Vasopressin Injections. The recall involves injections produced from January 1, 2009 to July 27, 2011. 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 # 0517-0410-10

• Lot 9677, Exp Date: October 2011; Exp Period: 24 months
• Lot 0052; Exp Date: January 2012; Exp Period: 24 months
• Lot 0294; Exp Date: October 2011; Exp Period: 18 months
• Lot 0442; Exp Date: December 2011 Months; Exp Period: 18 months
• Lot 0663; Exp Date: April 2012; Exp Period:

Vasopressin Injection, USP 20 units/mL, 1 mL multiple dose vial, Package Size: NDC # 0517-1020-25


• Lot 9532; Exp Date: August 2011; Exp Period: 24 Months
• Lot 9618; Exp Date: September 2011; Exp Period: 24 Months
• Lot 9707; Exp Date: October 2011; Exp Period: 24 months
• Lot 0104; Exp Date: February 2012; Exp Period: 24 months
• Lot 0124; Exp Date: February 2012; Exp Period: 24 months
• Lot 0273; Exp Date: October 2011; Exp Period: 18 months
• Lot 0346; Exp Date: November 2011; Exp Period: 18 months
• Lot 0400; Exp Date: December 2011; Exp Period: 18 months
• Lot 0437; Exp Date: December 2011; Exp Period: 18 months
• Lot 0618; Exp Date: March 2012; Exp Period: 18 months
• Lot 0758; Exp Date: May 2012; Exp Period: 18 months

Vasopressin Injection, USP 10 units/0.5 mL, 0.5 mL multiple dose vial Package Size: 25, NDC # 0517-0510-25

• Lot 0103; Exp Date: February 2012; Exp Period: 24 months

Hospitals, infusion centers, clinics, retail pharmacies and other healthcare facilities should not use the defective, recalled American Regent, Inc., Vasopressin Injection, USP Multiple Dose Vials and should immediately quarantine any product for return to American Regent Inc. American Regent, Inc. will credit accounts for all returned product in these lots. American Regent Customer Service Department can be reached, toll-free, at 1.877.788.3232, Monday through Friday from 8:30 a.m. to 7:00 p.m., Eastern Daylight Time (EDT).

Adverse reactions experienced with the use of this product should be reported to American Regent, Inc. by email at pv@luitpold.com; by fax to 1.610.650.0170; or by telephone to 1.800.734.9236, Monday through Friday from 9:00 a.m. to 5:00 p.m. EDT.

Adverse reactions or quality problems experienced with the use of this product may also 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 here, and mail to the address on the pre-addressed form; or by fax to 1.800.FDA.0178.

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