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The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.
On June 4, 2018, Hospira, Inc., a Pfizer company, announced it was 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. The recall was issued because embedded and loose particulate matter on the syringe plunger may be present.
According to the company, the risk of developing adverse events is low, and that risk is reduced because the product’s label directs users to visually inspect the product prior to administration. Adverse reactions may include local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.
The recalled lots were distributed nationwide to wholesalers, distributors, and hospitals in the United States, Puerto Rico, and Guam from February 2017 to February 2018. As of June 4, no adverse events associated with the recalled product were reported. Adverse events may be reported to FDA via its MedWatch program.
Naloxone Hydrochloride, an opioid antagonist, is used to treat 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, intramuscular, and subcutaneous administration.