naloxone FDA Alerts
The FDA Alert(s) below may be specifically about naloxone or relate to a group or class of drugs which include naloxone.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for naloxone
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter
Jun 4, 2018
Audience: Pain Management, Pharmacy, Anesthesiology, Emergency Medicine, HealthProfessional
ISSUE: Hospira, Inc., 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.To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.
BACKGROUND: 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.
RECOMMENDATION: Distributors or retailers with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
Healthcare Professionals with questions regarding this recall can contact Pfizer using the information in the recall notice.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
More naloxone Resources
- Naloxone Consumer Information
- Naloxone nasal Consumer Information
- Naloxone Auto-Injection Consumer Information
- Naloxone Injection Consumer Information
- Naloxone Nasal Spray Consumer Information
- Naloxone Injection Advanced Consumer Information
- Naloxone Nasal Advanced Consumer Information
- Naloxone Hydrochloride AHFS DI Monograph
- Naloxone Prescribing Information
- Naloxone Injection Prescribing Information
- Naloxone A-Z Drug Facts