Hospira, a Pfizer company, is voluntarily 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), to the hospital/institution level due to 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 risk is reduced by the possibility of detection, as the labeling contains a clear statement directing 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.
Naloxone Hydrochloride, an opioid antagonist, is indicated for the complete or partial reversal of opioid depression. It is also indicated for the diagnosis of known or suspected opioid overdosage, and as an adjunctive agent for the management of septic shock. It is available as a sterile solution for intravenous (IV), intramuscular (IM), and subcutaneous (SC) administration. Naloxone is supplied in a Carpuject single-use cartridge with a 1 mL fill for use with the Carpuject syringe system.
(Source: The U.S. Food and Drug Administration)