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Safety

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.


 

American Regent Initiates Voluntary Nationwide Recall of
Bacteriostatic Sodium Chloride Injection, USP, 0.9%
30 mL Multiple Dose Vials


Contact:

Walter Tozzi, R.Ph., M.S., M.B.A.
Sr. Director of Professional Services
631-924-4000


FOR IMMEDIATE RELEASE
- March 15, 2011 - 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

PLEASE NOTE: This recall, initiated on March 15, 2011 to the User Level, is for the following lots of Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials:

Lot #Expiration DateFirst Distribution Date
933005/201106/18/2009
959908/201110/12/2009
982812/201103/16/2010

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.

The product was distributed to wholesalers and distributors nationwide.

Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used for preparing and diluting sterile solutions.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Bacteriostatic Sodium Chloride Injection, USP, 30 mL Multiple Dose Vials with the lot #s listed above for patient care and should immediately quarantine any product for return.

American Regent has identified the source of the particulates and has taken the necessary steps to correct this issue. The company is initiating this voluntary recall for these lots manufactured prior to the implementation of this corrective action. 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 Bacteriostatic 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 these lot #s. 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 ET.

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 email at PV@luitpold.com, by fax to (610) 650-7781 or (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.


 

Bacteriostatic Sodium Chloride Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).


Source: Luitpold Pharmaceuticals, Inc.

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