Drugmaker Hospira issued a nationwide recall for two lots of its injectable opioid overdose antidote Naloxone over the potential presence of embedded and loose particulate matter on the syringe plunger.
"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 recall notice reads.
Naloxone Hydrochloride is used to completely or partially reverse opioid overdoses and depression and is available as a sterile solution for IV, intramuscular and subcutaneous administration.
The recall affects single-use cartage units with lot numbers 72680LL and 76510LL. The affected products were sent to wholesalers, distributors and hospitals across the U.S., Puerto Rico and Guam between February 2017 and February 2018.
While no adverse events have been reported to date as a result of the particulate matter, the FDA is encouraging anyone who experiences a related adverse event to report it.