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American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP
Date:2/3/2011

SHIRLEY, N.Y., Feb. 3, 2011 /PRNewswire/ -- 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
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SOURCE Luitpold Pharmaceuticals, Inc.
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