American Regent Initiates Nationwide Voluntary Recall of Sterile Water for Injection, USP 50 mL Single Dose Vial Due to Particulate Matter

Date of Recall

2011-05-20

Recall Details

- May 19, 2011 - Shirley, NY - 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. No other lots or sizes of Sterile Water for Injection, USP are subject to this voluntary recall.

This voluntary recall was initiated because some of the vials of this lot may contain rust like particulate matter. 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. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues, if this lot of Sterile Water for Injection, USP is administered to patients.

Sterile Water for Injection, USP is to be used only as a diluent. It is not isotonic and should not be injected directly into the body.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, Emergency Rooms, Clinics, Physician Offices and other healthcare facilities and providers should not use American Regent Inc., Sterile Water for Injection, USP, 50 mL Single Dose Vials, with Lot 0092, for patient care and should immediately quarantine any product for return.

American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned product with lot 0092. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM EDT.

Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers, or patients 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.

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via email at [email protected] by fax to (610) 650-0170 or by phone
at 1-800-734-9236. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL 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, or 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

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.

As is standard practice, and as stated in the Sterile Water for Injection, USP, Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit."

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

Source: Luitpold Pharmaceuticals, Inc.

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

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