American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP 10% (100 mg/mL) 10 mL Single Dose Vials Lot# 0056 Due to Translucent Visible Particles

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP 10% (100 mg/mL) 10 mL Single Dose Vials Lot# 0056 Due to Translucent Visible Particles

American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP 10% (100 mg/mL) 10 mL Single Dose Vials Lot# 0056 Due to Translucent Visible Particles
Thu, 03 Feb 2011 17:31:00 -0600

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.

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