American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4% 30 mL Single Dose Vials and 100 mL Pharmacy Bulk Packs

Date of Recall

2011-03-16

Recall Details

- March 15, 2011 - American Regent is conducting a voluntary nationwide recall of the following products:

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

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. See attached APPENDIX for ALL the lots subject to this recall.

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 [email protected], 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.

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

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