U.S. Recalls / American Regent, Inc.

American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product: Sterile Water for Injection, USP, 50 mL Single Dose Vial, NDC # 0517-3050-25, Lot 0092, Exp. Date February, 2014 PLEASE NOTE: This recall, initiated on May 19, 2011 to the User or Consumer Level, is for Lot 0092 Only.

This voluntary recall was initiated because some of the vials of this lot may contain visible particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation.

This voluntary recall was initiated because some vials of this lot were observed to contain particulates. American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lungs, localized inflammation (swelling and accumulation of inflammatory cells), and granuloma formation.

This voluntary recall was initiated because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates. Potential adverse events after intravenous administration of solutions containing particulates, may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation.

This voluntary recall was initiated because some of the vials of these lots may contain visible particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if these lots of product are administered to patients.

American Regent is conducting a nationwide voluntary recall of the three lots listed below of the following product: Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL, Multiple Dose Vials NDC # 0517-0648-25

This voluntary recall was initiated because some vials of this lot exhibit translucent visible particles consistent with glass delamination. Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product: Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial NDC # 0517-2305-25 Lot #0048 Exp Date: January, 2012 PLEASE NOTE: This recall, initiated on February 3, 2011 to the User or Consumer Level, is for lot # 0048 Only.