The company’s naloxone injection, sold in its Carpuject single-use cartridge syringe, was recalled due to the potential presence of embedded and loose particulate matter in the plunger.
Hospira specifically warned that products from lots 72680LL and 76510LL should be taken out of use and quarantined immediately.
The company noted that it hasn’t yet received reports of any adverse events linked to the issue.
“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,” Hospira wrote in a notice posted to the FDA’s website.
Naloxone is an opioid antagonist designed to reverse an opioid overdose. The drug is delivered via intravenous, intramuscular and subcutaneous administration using an array of delivery systems, including Hospira’s Carpuject syringe system.
The products affected by the recall were distributed to wholesalers and hospitals in the U.S., Puerto Rico and Guam from February 2017 to February 2018.