American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP 10% (100 mg/mL) 10 mL Single Dose Via
Posted Feb 03 2011 6:31pm
FOR IMMEDIATE RELEASE - February 3, 2011 -American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:
Sodium Thiosulfate Injection, USP, 10% (100 mg/mL), 10 mL Single Dose Vial NDC # 0517-1019-05 Lot #0056 Exp Date: January, 2012
PLEASE NOTE: This recall, initiated on February 2, 2011 to the User or Consumer Level, is for lot # 0056 Only. No other lots or sizes of Sodium Thiosulfate Injection, USP are subject to this voluntary recall.
This voluntary recall was initiated because some vials of this lot exhibit translucent visible particles consistent with glass delamination. Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.
Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients.
Sodium Thiosulfate Injection, USP is indicated in the treatment of cyanide poisoning.
The product was distributed to wholesalers and distributors nationwide.
Hospitals, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use American Regent Inc., Sodium Thiosulfate Injection, USP, 10% (100mg/mL) 10 mL Single Dose Vial with lot # 0056 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 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 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@example.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.
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
“All of us at Luitpold Pharmaceuticals and American Regent are committed to taking the necessary steps to protect patients from any potential safety risks with our Sodium Thiosulfate Injection. The safety of patients receiving our products is our primary concern.” said Mary Jane Helenek, President and CEO of American Regent.
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 Sodium Thiosulfate 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.”
Sodium Thiosulfate 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.