Two lots of naloxone hydrochloride injections, USP have been recalled by Hospira, Inc., due to concerns regarding the presence of particulates on the syringe plunger.
The voluntary recall by the Pfizer subsidiary is for Carpuject single-use cartridge syringe system (NDC 0409-1782-69) of naloxone hydrochloride injection, USP (lots 72680LL and 76510LL; 0.4 mg/mL, 1 mL in 2.5 mL doses for both lots). Adverse events related to these lots are unlikely, according to the US Food and Drug Administration, and may be as mild as local irritation, but may also include pulmonary dysfunction, emboli, infarction, or toxicity.
Package labeling recommends visual inspection to detect the presence of discoloration or particulates before administration, which would diminish the risks for using these lots.
Any product-related adverse events may be reported on FDA’s MedWatch Adverse Event Reporting program.
“Distributors or retailers with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately.”
US Food and Drug Administration. Press release. Hospira issues a voluntary nationwide recall for two lots of naloxone hydrochloride injection, USP, in the Carpuject™ syringe system due to the potential presence of particulate matter. Accessed June 4, 2018.