Recalls

Another secondary recall linked to Hospira

Syringe Insulin Diabetis 435x326 Another secondary recall linked to Hospira Hospira Inc.’s June 15 recall of several injectable drugs due to the possibility that they may be contaminated with disease-causing microbial growth has resulted in another, secondary recall. Fagron Sterile Services announced it is recalling three lots of succinylcholine chloride syringes that were manufactured by Hospira, a Pfizer company, and repacked by Fagron Sterile Services. The potential contamination was identified during a routine simulation of Hospira’s manufacturing process.

In the event that a contaminated product is administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. No microorganisms have been confirmed in any Fagron Sterile Services products and, to date, there have been no reports of adverse events related to Fagron Sterile Services products affected by this recall.

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. Affected lots are repacked by Fagron Sterile Services into 5mL doses of succinylcholine chloride 20mg/mL. The impacted succinylcholine chloride 20mg/mL lots include Lot C274-000000331 with the beyond-use date 08/30/2017; Lot C274-000001274 with the beyond-use date 09/07/2017; and Lot C274-000001326 with the beyond-use date 09/14/2017.

The syringes were distributed to hospitals and surgical clinics nationwide. Fagron Sterile Services has notified its customers and arranged for return and replacement of all recalled products.

Any adverse events related to products in this recall should be reported to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Sources:
FDA Recall Notice
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