American Regent just initiated a nationwide voluntary recall of its Sodium Thiosulfate Injection, USP 10% (100 mg/mL) 10 mL Single Dose Vials Lot# 0056, the U.S. Food and Drug Administration (FDA) said.The drug recall, which was put in place due to translucent visible particles, involves the defective drug with NDC # 0517-1019-05 with an expiration date of January, 2012.
The drug recall was initiated on February 2, 2011 to the user or consumer level and only involves Lot # 0056. 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 defective drug lot exhibits 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 drug side effects, after intravenous administration, include damage to blood vessels in the lung, localized swelling, and granuloma formation.
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, and retailers in possession of the defective drug should stop its use.
American Regent will credit accounts for all returned product with this lot number. Those with questions about the return or recall process should call American Regent’s Customer Service Department, toll-free, at 1-877-788-3232. Customer Service can be reached Monday through Friday from 8:30 a.m. to 7:00 p.m. Eastern Time.
Hospitals, emergency rooms, infusion centers, clinics and healthcare providers, or patients with product quality complaints, medical, or other questions concerning the use of this recalled drug can contact the Professional Services Department at 1-877-788-3232.
Any adverse reactions experienced with the use of this Recalled Drug 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 for reporting of specific adverse events related to this Recalled Drug only.
Also, adverse reactions or quality problems experienced with the use of this Defective Drug may be reported to the FDA’s MedWatch Adverse Event Reporting program online, or regular mail or by fax, and online; by regular mail, use the postage-paid, pre-addressed Form FDA 3500 available and mail to the address on the pre-addressed form; and by fax to 1-800-FDA-0178.
Sodium Thiosulfate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. located in Shirley, NY.
