Opioid Overdose Antidote Recalled Due to Particulate Matter


The FDA announced a recall of Naloxone on Monday after the antidote’s manufacturer flagged a potential issue with the syringe plunger. Hospira Inc., which is a Pfizer company, said the potential presence of embedded and loos particulate matter could cause a patient to experience adverse effects such as irritation, allergic reactions, pulmonary dysfunction or others.

In the midst of an opioid addiction and overdose epidemic that appears to only be getting worse, the company that manufactures naloxone—an antidote for opioid overdoses that U.S. Surgeon General Jerome Adams has recommended more Americans carry with them—has issued a nationwide recall for two lots of the drug. The reason? Those batches of naloxone may be contaminated with “embedded and loose particulate matter” on the syringe plunger that could cause harmful side effects. And it’s the latest in a string of supply chain mishaps for naloxone manufacturer Hospira and its parent company, drug giant Pfizer.

“In the event that impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity,” Pfizer stated in its voluntary recall notice with the Food and Drug Administration (FDA).

Pfizer notes that there haven’t been any adverse event reports related to the recalled naloxone lots to date. The drug is now commonly carried by first responders and family members of opioid painkiller and heroin addicts as it can reverse deadly overdose symptoms like the inability to breathe.

But this is far from the first significant public health concern stemming from problems at Hospira, which Pfizer bought out in a $17 billion deal back in 2015. My Fortune colleague Erika Fry detailed the myriad issues at the company, and how they’ve put the squeeze on hospitals and patients seeking basic, critical injectable drugs like saline, sodium bicarbonate, and others, in a recent feature.

“The simple answer to why America currently has so many shortages of generic sterile injectable drugs: America’s leading manufacturer of generic sterile injectable drugs hasn’t been making them,” writes Erika of Hospira, noting that the firm “had 370 products that are depleted or in limited supply, 102 of which the company has indicated will not be available until 2019” as of May 11.

There a number of reasons behind the manufacturing woes, including shuttered facilities awaiting upgrades and the bombshell of Hurricane Maria in Puerto Rico, where many common generic injectable and IV drugs are manufactured. It also doesn’t help that Pfizer and Hospira virtually control the entirety of the market for many of these medicines, forcing nationwide recalls with outsize effect when something goes wrong. But with the opioid epidemic raging on, claiming tens of thousands of lives every day, the naloxone recall could hit particularly hard, if only temporarily.


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