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Home » Santa Clarita News » Recalls » Sodium Chloride Solution Recalled For Particulate Contamination

Sodium Chloride Solution Recalled For Particulate Contamination

khts_recallsAmerican Regent is recalling certain lots of concentrated sodium chloride injection solution due to visible particulates that could injure patients.

 

American Regent is conducting a voluntary nationwide recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial NDC # 0517-2930-25 and Concentrated Sodium Chloride Injection, USP, 23.4%, 100 mL Pharmacy Bulk Package NDC # 0517-2900-25.


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PLEASE NOTE: This voluntary nationwide recall, initiated on March 15, 2011 to the User Level, is for Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages.

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.

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% with the lot #s on the attached Appendix 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 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 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.

Online: www.fda.gov/medwatch/report.htm1

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

APPENDIX

Recalled Lots of Concentrated Sodium Chloride Injection, USP, 23.4%

Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial NDC # 0517-2930-25

Lot#

Expiration Date

First Distribution Date

9198

03/31/2011

04/21/2009

9252

04/30/2011

05/21/2009

9299

04/30/2011

06/01/2009

9305

05/31/2011

06/23/2009

9402

06/30/2011

07/13/2009

9423

06/30/2011

07/30/2009

9432

06/30/2011

08/20/2009

9553

08/31/2011

09/11/2009

9595

08/31/2011

10/05/2009

 

 

 

9646

09/30/2011

10/28/2009

9681

10/31/2011

11/23/2009

9737

10/31/2011

12/21/2009

9797

11/30/2011

01/11/2010

9831

12/31/2011

02/08/2010

0051

01/31/2012

03/02/2010

0095

02/28/2012

03/17/2010

Concentrated Sodium Chloride Injection, USP, 23.4%, 100 mL Pharmacy Bulk Package NDC # 0517-2900-25

Lot #

Expiration Date

First Distribution Date

9225

04/30/2011

05/06/2009

9492

07/31/2011

08/07/2009

9711

10/31/2011

11/03/2009

0007

01/31/2012

01/26/2010

0058

01/31/2012

03/02/2010

 

Sodium Chloride Solution Recalled For Particulate Contamination

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