Opioid Antidote Naloxone Recalled By Manufacturer

By Paul Fuhr 06/07/18

A batch of units sold between February 2017 and February 2018 are being recalled by the manufacturer. 

a box of naloxone vials

The life-saving opioid overdose antidote naloxone has been recalled by its manufacturer, the Food and Drug Administration (FDA) announced.

Drug company Hospira and its parent company Pfizer issued the recall on Monday, CNN reported, after discovering “loose particulate matter on the syringe plunger.”

While no one has yet reported problems with the drug, Pfizer isn’t taking any chances. “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,” the drug maker said in its recall.

Known by its brand name Narcan, naloxone has made headlines in recent years for its role in the nation’s opioid crisis, as it rapidly reverses the effects of overdoses.

The drug is widely carried by ER doctors, paramedics and specially trained first responders, as well as the family members of people addicted to prescription painkillers and opioid users. (Previously, the drug was only available through hospitals, CNN noted.)

First developed in 1961, naloxone quickly proved itself to be as effective as it is fast-acting. The drug has virtually no side effects and only stays in a person’s system for up to 90 minutes.

“The sooner the drug is given, the better the result, because the brain of a person who isn’t breathing is being deprived of oxygen,” the Cleveland Clinic’s Dr. Thomas Waters told Health. It doesn’t reverse alcohol or non-opioid drug overdoses, though.

There are currently three FDA-approved forms of naloxone, including injectable vials, autoinjectable devices and a pre-packaged nasal spray.

According to the National Institute on Drug Abuse, naloxone acts as an opioid antagonist, binding to opioid receptors in the brain: “[The drug] can very quickly restore normal respiration to a person whose breathing has slowed or stopped as a result of overdosing with heroin or prescription opioid pain medications.”

The drug recall affects single-use sterile cartridge units “with lot numbers 72680LL and 76510LL in 0.4 mg/ml, 1 mL in, and 2.5 mL strengths,” CNN reports.

CNN added that the units were sold to wholesalers, hospitals and distributors in the United States, Puerto Rico and Guam between February 2017 and February 2018. 

Fortune noted that the naloxone recall is just “the latest black eye” for Hospira, citing manufacturing shortages, lawsuits, staff cuts and warning letters from the FDA as problems that have plagued the company in recent years. The company’s Puerto Rico facilities, where many generic injectable and IV drugs were made, were shuttered after the “bombshell of Hurricane Maria” last year.

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Paul Fuhr lives in Columbus, Ohio with his family and two cats, Vesper and Dr. No. He's written for AfterParty MagazineThe Literary Review and The Live Oak Review, among others. He's also the host of "Drop the Needle," a podcast about music and addiction recovery. More at paulfuhr.com. You can also find Paul on Linkedin and Twitter.