American Regent Recalls One Lot of Sodium Thiosulfate Injection Due to Particulates

The following recall is being posted as some veterinarians may use this product in treating their patients.

Customer Service: (877) 788-3232

American Regent is recalling One Lot of Sodium Thiosulfate Injection, USP, 10% (100 mg/mL), 10 mL Single Dose Vial due to particulate contamination.

The lot information is as follows:

  • NDC # 0517-1019-05
  • Lot #0056
  • Exp Date: January, 2012

This 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 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.