Makers of opioid overdose antidote Naloxone, Hospira, has issued a nationwide recall of Naloxone. The reason for the recall is that a particulate matter was found on a portion of the delivery system of the drug.
Exposure to these particulates could have adverse health effects on users of Naloxone.
The loose particulate matter was found on the syringe plunger of the drug. Hospira says that there is a low chance people will experience a wide range of adverse health effects but decided to recall the drug just in case. It added that it hasn’t received any complaints about the Naloxone that is being recalled.
Hospira is voluntarily issuing the recall of Naloxone. It has asked distributors and retailers to stop using the recalled Naloxone. In the press release put out by the Food and Drug Administration, Hospira says that it is recalling lots 72680LL and 76510LL of Naloxone. These were sent to wholesalers, distributors, and hospital in the United States, Puerto Rico and Guam from February 2017 to February 2018.
Hospira says that there is a potential presence of embedded and loose particulate matter on the syringe plunger. Patients who come into contact with the particulate matter may suffer from the following local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.
Users can inspect the Naloxone before it is administered to a person by looking for particulate matter near the syringe and looking for discoloration before it is administered. People who have experienced adverse effects from the particulate matter should contact the FDA.
Naloxone is used to combat opioid overdoses. When it is used it is able to restore normal breathing in someone who stopped breathing due to using opioids. Due to the opioid epidemic, it is being carried by first responders.
Naloxone is also available in the intravenous form, intramuscular, and subcutaneous. This recall by Hospira only affects the single-use sterile cartridges in 0.4 mg/ml, 1 mL in, and 2.5 mL strengths.
The CDC released a report in March that shows that 115 Americans are dying every day from the opioid epidemic. The data came from the fatal overdose from 31 states that produced reliable reports of drug-related causes of death. A total of 63,623 Americans died from a drug overdose in 2016, 66 percent of those deaths were due to opioid usage.
Some of the states that were hardest hit by the opioid epidemic include West Virginia, New Hampshire, Ohio, the District of Columbia, Maryland, and Massachusetts.