FDA Alert on Pfizer/Hospira Drug Shortages

FDA is alerting healthcare professionals about an ongoing shortage affecting several injectable drugs made by Pfizer’s Hospira unit, including sodium bicarbonate injection (vials and syringes), dextrose 50% injection (vials and syringes), and emergency syringes of other drugs, including epinephrine, calcium chloride and atropine sulfate.  Pfizer says the shortage is caused by manufacturing, distribution and third party delays, according to the agency alert.

“We are working closely with Pfizer to resolve these critical shortages by addressing the underlying causes,” FDA says. “The agency is working to relieve these shortages through a variety of measures, including finding alternative manufacturers of these drug products. FDA continues to explore all available options, which may include expediting review of applications or other submissions, or considering temporary regulatory flexibility for alternative sources.”

Some emergency syringes have had their use dates extended based on stability data provided by Pfizer, FDA says. The information about the specific lots with extended use dates is found in these tables.