American Regent continues to fight glass delamination. It issued another voluntary recall on Monday, this time for the hypertension treatment Methyldopate HCL Injection, 250 mg/5 mL, in single-dose vials. The recall concerns only one lot, the company says, now at the user/consumer level.
Some of the vials being recalled contained translucent visible particles of less than 50 microns to 200 microns, consistent with glass delamination. The company has asked healthcare facilities to find and quarantine for return all affected product.
The drug is manufactured by Luitpold Pharmaceuticals and distributed by New York-based American Regent.
Regent just recently resumed shipments for another drug, iron-sucrose injection Venofer, while it worked with the FDA to prioritize critical medications for assessment prior to distribution. The shipping restart follows an investigation into glass delamination, which ultimately led to a production suspension. And the distributor was working two recalls at the beginning of the year, both involving particle contamination in injectable products.
Drug quality and authenticity consortium Rx-360 began sounding the glass-delamination alarm in January by sending alerts on the plague of particle-contaminated injectables that began in mid-2010 and extends beyond American Regent. It cited sub-par vial glass as a culprit.
- here's the current recall notice