Sodium Thiosulfate Injection Recall Issued Due to Translucent Particles

Flakes of glass have been found floating in some vials of sodium thiosulfate injections made by American Regent, leading to a recall. 

The sodium thiosulfate recall was announced on February 2 by American Regent after the some vials were found to contain fragments visible, translucent particles, according to an FDA announcement. The company believes that the particles are the result of glass delamination, which occurs when solutions with a high pH strip away surface glass within the vial, causing particles with a flaky appearance.

If injected, the particles could cause damage to blood vessels in the lungs, swelling and granuloma formation. However, there have been no injuries or illnesses reported in connection with this recall.

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Sodium thiosulfate injections are an antidote to cyanide poisoning, used as part of a treatment for patients suffering kidney disease, and sometimes used during chemotherapy.

The recall affects one lot of sodium thiosulfate injection, USP, 10% (100 mg/mL) by American Regent. It was distributed in 10 mL single dose vials under NDC # 0517-1019-05 and Lot #0056. The vials have an expiration date of January, 2012.

American Regent recommends that any hospitals, emergency rooms, infusion centers, clinics or other healthcare facilities that have the affected vials in stock immediately quarantine them and not use them. The company says it is notifying distributors and consumers to arrange for the return of all of the recalled vials.

Anyone with questions should contact American Regent’s customer service department at 1-877-788-3232. Anyone who has suffered adverse effects from the recalled injections should report them to FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

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