Recall -- Firm Press Release
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American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates
Walter Tozzi, R.Ph., M.S., M.B.A.
Sr. Director of Professional Services
FOR IMMEDIATE RELEASE - June 15, 2011 -American Regent is conducting a voluntary nationwide recall to the user and consumer level of the following product:
Lot #0362, Expiration Date May 2012, NDC # 0517-2930-25
PLEASE NOTE: This voluntary nationwide recall, initiated on June 14, 2011 to the consumer and user level is for lot # 0362 only. No other sizes or lots of Concentrated Sodium Chloride Injection, USP are subject to this voluntary recall.
This voluntary recall was initiated because some of the vials of this lot 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.
Concentrated Sodium Chloride Injection, USP, 23.4% is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirement of the patient with unusual fluid and electrolyte needs.
The product was distributed to wholesalers and distributors nationwide.
Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Concentrated Sodium Chloride Injection, USP, 23.4%, Lot # 0362 for patient care and should immediately quarantine any product for return.
As is standard practice, and as stated in the Concentrated Sodium Chloride 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.”
American Regent will credit accounts for all returned product with this lot #. 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, infusion centers, clinics and healthcare 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 e-mail at email@example.com, 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 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: 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.
Concentrated Sodium Chloride 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 & Drug Administration.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.