Hospira Sterility Problems Cause Another Recall

June 26, 2017

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

Fagron Sterile Services announced on June 23, 2017 that it is voluntarily recalling three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level because of sterility assurance concerns. The recalled product is manufactured by Hospira, a Pfizer company, and repacked by Fagron Sterile Services. The impacted lots were distributed nationwide.

During a routine simulation of its manufacturing process, Hospira detected microbial growth, prompting several recalls of a variety of products. The product is being recalled out of caution because, according to Hospira, patients may experience adverse events ranging from fever and chills to systemic invasive mycoses or systemic bacterial sepsis if contaminated product is administered. Neither Hospira or Fagron Sterile Services has, to date, received any reports of adverse events associated with the recalled product.

Succinylcholine Chloride Injection is used as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. It is repacked by Fagron Sterile Services into 5mL doses of Succinylcholine Chloride 20mg/mL. Adverse events can be reported to FDA at www.fda.gov/medwatch/report.htm.

Source: FDA