Drugmaker Recalls Contaminated Naloxone Syringes

Drugmaker Recalls Contaminated Naloxone Syringes

Hospira, maker of Carpuject naloxone syringes, has begun a voluntary nationwide recall of two lots of the life-saving drug injectors. The company said there is no danger from the naloxone itself, but there could be from "embedded or loose particulate matter" discovered in the plastic syringe itself.

The two lots were distributed to hospitals and institutions across the U.S., Puerto Rico and Guam throughout the year from February 2017 to February 2018.

Hospira, Inc., a Pfizer company, is recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69).

The Food and Drug Administration (FDA) announced the safety alert on its MedWatch site. The FDA issued the recall over fear that the syringes contain potentially dangerous loose particles.

Low likelihood of harm

A statement from Hospira says that,

the threat of harm from ingesting the particles is low, as directions for use require visually checking syringe solution before administering it. But they said adverse effects could include irritation, allergic reaction and toxicity, among others.

The FDA echoed the company's statement, saying patients would have,

"a low likelihood" of experiencing adverse events because the labeling clearly calls for direct visual inspection of the product "for particulate matter and discoloration prior to administration."

To date, Hospira,

"has not received reports of any adverse events associated with this issue for these lots," the FDA added. But adverse reactions could include local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

Naloxone in the news

Naloxone is such a miracle worker that it's been frequently in the news for several years.

Naloxone can reverse an opioid overdose and save a person's life. It isn't an opioid, and isn't harmful to someone who isn't overdosing. It doesn't work for alcohol, cocaine, or any other non-opioid drugs.

It's been in regular use since the mid-1990s, when opioid ODs started to increase along with the explosion in prescriptions for OxyContin and other opioid painkillers. In the last few years, as the opioid crisis has soared, naloxone has become almost a household word.

Just a few weeks ago, Surgeon General Jerome Adams urged anyone with friends or family at risk of opioid overdose to carry naloxone, and also to keep it available at home. In a speech to the National Rx Drug Abuse & Heroin Summit in Atlanta, Adams said that more than half of all opioid overdose deaths occur at home.

Time is of the essence when someone overdoses on opioids. It's even more critical when someone ODs on super-opioids like fentanyl and carfentanil.

Police and paramedics now carry naloxone routinely. But they can't always reach an overdose victim in time. If someone nearby has naloxone handy, they can save a life.

"You don't have to be a policeman or a firefighter or a paramedic to save a life," Adams said.

Start Your New Path to Sobriety Today!

    • Please enter your name.
    • This isn't a valid phone number.
    • Please enter your email address.
      This isn't a valid email address.
    • Please make a selection.
    • Please enter a message.