Hospira Inc., a Pfizer company, is recalling two lots of the opioid overdose reversal agent Naloxone Hydrochloride injection because there may be bits of particulate matter embedded and loose on the Carpuject Single-use cartridge syringe plunger.
If the drug is administered to a patient, there is a chance the patient could experience a range of adverse events including local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity. To date, Hospira has not received any reports of adverse events related to this issue.
The recall affects lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use syringe system (NDC 0409-1782-69). The drug was distributed nationwide to wholesalers, distributors and hospitals in the U.S., Puerto Rico and Guam from February 2017 to February 2018.
Naloxone Hydrochloride is an opioid antagonist used for the complete or partial reversal of opioid depression. It is also used to diagnose known or suspected opioid over-dosage, and as an adjunctive agent for the management of septic shock.
Hospira has notified its wholesalers, distributors and hospitals of this recall and is arranging for a return of all products. The wholesalers, distributors and hospitals have also been asked to notify others that may have received the product from them and inform them about the recall.
Any adverse events or quality problems related to these recalled lots of Naloxone Hydrochloride should file a report with the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice