Naloxone recall due to particulate matter


ROCKFORD, IL – JULY 14: A Rockford firefighter shows a dose of Naloxone which the division carries on their ambulances to deal with opioid drug overdoses on July 14, 2017 in Rockford, Illinois. Rockford, a metropolis of about 150,000 positioned in northern Illinois, averages about 2 overdose deaths per week, nearly all of that are heroin associated. Nationwide, an estimated 60,000 individuals within the U.S. died from drug overdoses in 2016, greater than gunshots or visitors accidents. (Photo by Scott Olson/Getty Images)

NEW YORK — The opioid overdose antidote Naloxone has been recalled by its maker, Hospira, the US Food and Drug Administration said Monday.

The recall was prompted by the potential for “loose particulate matter on the syringe plunger” which might lead to a spread of antagonistic occasions. “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.”

No cases of antagonistic occasions have been reported, in accordance to the recall announcement. Anyone who experiences a associated antagonistic occasion ought to report it to the FDA.

Naloxone Hydrochloride is bought for IV use, intramuscular use and subcutaneous use. The recall impacts single use sterile cartridge items with lot numbers 72680LL and 76510LL in 0.4 mg/ml, 1 mL in, and 2.5 mL strengths. They had been despatched to wholesalers, distributors and hospitals within the United states, Puerto Rico and Guam between February 2017 and February 2018.

Hospira is asking distributors and retailers to discontinue utilizing and distributing the recalled product and notify anybody who they’ve despatched it to together with shops, pharmacies and hospitals.

Naloxone used to solely be obtainable in hospitals however is now carried by many first responders, medical professionals and is obtainable with no prescription in some locations, all in response to the continued opioid epidemic.

When administered, Naloxone can rapidly restore regular respiration to somebody whose respiratory has slowed or stopped due to opioids.


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