“One unit that produces certain injectable medicines is completing a major upgrade that has taken longer than expected and was out of production for about five weeks longer than initially anticipated,” Pfizer spokesman Steven Danehy told In-Pharmatechnologist.com.
“We only resumed production once we were certain that the unit would meet Pfizer’s standards for quality and compliance.”
The shortage, first announced by the FDA, will cause a short-term backorder, though availability of the injections is expected to be better in the first week of March. Full recovery, however, is “not expected until June 2014,” according to the FDA.
Methylprednisolone sodium succinate injections, better known as Solu-Medrol, are corticosteroids used to relieve inflammation.
According to the American Society of Health-System Pharmacists (ASHP), Pfizer isn’t the only company with issues with these injections.
Hospira discontinued all of its methylprednisolone sodium succinate products in January 2013 due to raw material issues, and Bedford Laboratories discontinued making these products in 2011 to concentrate on others.
“We are working to resolve this situation as quickly as possible and expect that initial shipments of new production from Kalamazoo to Market Distribution Centers will resume by the first week of March,” Danehy said, noting the delay could cause shortages of multiple products.
The FDA also calls on hospitals and physicians to check with wholesalers for available inventory. ASHP said Fresenius Kabi has 40 mg vials of the injection on back order and the company “cannot estimate a release date.”
As far as how Pfizer will deal with future shortages, the company says it “has in place a rigorous quality assurance system to ensure that our medicines and health care products are produced in accordance with Pfizer’s quality standards and regulatory guidelines. All our manufacturing and quality processes are conducted in strict accordance with FDA’s current Good Manufacturing Practice Guidelines,” according to Danehy.