Medication Monitor

Generic Name (Trade Name—Company)
June 28, 2017

Succinylcholine chloride 20 mg/mL 5 mL syringe

(No trade name—Fagron Sterile Services)
Three lots of surgical product lack sterility assurance

Fagron Sterile Services is voluntarily recalling three lots (#C274-000000331, #C274-000001274, and #C274-000001326) of succinylcholine chloride 20 mg/mL 5 mL syringe to the hospital/clinic level because microbial growth was detected during a routine simulation during the manufacturing process. The affected lots were distributed nationwide directly to hospitals and surgical clinics.

This secondary recall is being conducted as result of the recall initiated by the manufacturer on June 15, 2017.

If the affected product is administered to a patient, the patient may experience adverse events ranging from fever, chills, and malaise to severe adverse events such as systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No microorganisms have been confirmed in any Fagron Sterile Services lot.

To date, Fagron Sterile Services has not received reports of any adverse events associated with this issue.

The product is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.