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Drug Recall: Two lots of Naloxone injection recalled

by
Optum Workers' Comp
| Jun 06, 2018

The U.S. Food and Drug Administration (FDA) announced that Hospira, Inc., a Pfizer company, voluntarily recalled two lots of naloxone hydrochloride injection at the hospital and institution level. Naloxone injection is used in the emergency treatment of a known or suspected opioid overdose. However, this recall does not affect the naloxone products Evzio® auto-injector or Narcan® Nasal Spray.

The two lots of naloxone injection are being recalled due to the potential presence of embedded and loose particulate matter on the syringe plunger. The company has stated that if this product is administered to a patient, there is a low likelihood of experiencing adverse effects. Moreover, to date, the company has not received any reports of any adverse events associated with these lots.

Product lots were distributed nationwide to wholesalers/distributors/hospitals in the United States, Puerto Rico, and Guam from February 2017 to February 2018. The following lots are included in this recall:


Hospira has notified its distributors, wholesalers, and hospitals to arrange for the return of all recalled products. Any facilities with these naloxone products should stop using them immediately and arrange for a return.

Because these products are typically administered by healthcare professionals at the hospital and institution level, there has been a minimal impact in our book of business. Patients who are not sure if they have been prescribed one of these products or have questions, should contact their prescriber or healthcare provider.

For more information on this recall and contact information for Pfizer, please click here

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

  1. U.S. Food and Drug Administration Safety Recalls, Market Withdrawals and Safety Alerts. Company Announcement. 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. June 4, 2018. Available at: https://www.fda.gov/Safety/Recalls/ucm609668.htm. [Accessed 4 Jun. 2018]