A voluntary recall by Hospira and Teva’s decision to close its troubled Irvine, California, manufacturing facility have combined to put a pinch in the production of propofol, which the FDA lists as among drugs in short supply.
News of Hospira's recall of one lot of propofol injectable emulsion hit the regulatory agency’s website just as Teva confirmed in an email to Fierce Pharma that it was shuttering its Irvine facility.
Hospira, a Pfizer subsidiary, is recalling 100-mL, single-use vials after an internal inspection revealed visible particulates in two vials. To date, the company hasn’t received any reports of patient injuries related to the lot.
The recall affects lot EA7470, which Hospira distributed nationwide to wholesalers and hospitals between July 16, 2020, and July 24, 2020.
Propofol, which is primarily used to relax or put patients to sleep prior to surgery or other medical procedures, has been in short supply for several years as the number of manufacturers of the drug have dwindled. The short supply became acute during the height of the COVID-19 pandemic as it was used to sedate coronavirus patients who were on ventilators in intensive care units.
As for Teva, the company halted operations at its troubled Irvine site last October in response to FDA concerns about contamination issues that triggered recalls earlier in 2021. This week, a Teva spokesperson said the facility "will not resume production and the company is either transferring or ceasing production of medicines made at the site."
On the FDA's website, the agency says Teva has discontinued its propofol production and that the company's supplies to the market are set to run out next spring.
Teva's Irvine site was at the center of a large propofol recall back in 2009. Afterward, Teva said it would stop making the product, but the company returned to the market in 2013.