American Regent: Not Waiting for the Watchdog

Many experts have long since concluded that the U.S. Food and Drug Administration (FDA) is a bit overwhelmed and undermanned, perhaps even rudderless at times. They seem to have had a hard time keeping their eye on the ball ever since the Vioxx debacle. Even so, the federal government has plenty of clout among the industries under their jurisdiction, particularly drug makers, as seen in the recent voluntary recall by distributor American Regent of Concentrated Sodium Chloride Injections, USP 23.4% (in the 30ml single-dose vial).

An Uncommon Problem

Sodium chloride injections – Luitpold Pharmaceuticals made this particular batch – are administered to patients who have electrolyte imbalances as an additive to parenteral fluid therapy. They are sometimes susceptible to particulate buildup, which is warned against by the drug maker along with a caveat that all injections should be visibly inspected for particulates before use.

Particulates Matter

The batch in question, says American Regent, must be immediately placed in quarantine (with credit applied to the user account). This recall applies to both patients and to those among the medical profession who administer the injections. Adverse effects for those who are given the tainted injections could include disruption of blood flow to small blood vessels in the lungs, as well as inflammation and granuloma formation.
Not waiting the FDA to bring action – however long that might have taken – was not an option for American Regent, who is conducting this recall after having fully informed the government agency about the problems with Concentrated Sodium Chloride Injections, USP 23.4%. The voluntary, nationwide recall only covers the 30ml single-dose vials. Patients who have experienced adverse reactions are urged to contact American Regent at 1-800-734-9236.