domingo, 25 de junio de 2017

FDA MedWatch - Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance 
AUDIENCE: Pharmacy, Critical Care Medicine
ISSUE: Fagron Sterile Services is voluntarily recalling three (3) lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level. The secondary recall of product manufactured by Hospira Inc., a Pfizer company, and repacked by Fagron Sterile Services, is due to microbial growth detected during a routine simulation of Hospira’s manufacturing process, which represents the potential introduction of microorganisms into the product. To date, there have been no reports of adverse events. This secondary recall is being conducted as result of the recall initiated by the manufacturer on June 15, 2017.
Per Hospira, in the event that impacted 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. 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. See the press release for a list of affected Lot Numbers. The impacted lots were distributed nationwide directly to hospitals and surgical clinics.
BACKGROUND: Succinylcholine Chloride Injection is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
RECOMMENDATION: Fagron Sterile Services has notified its direct customers by telephone and is arranging for return and replacement of all recalled products. Hospitals or surgical clinics that have received impacted product which is being recalled, should immediately examine stock and discontinue dispensing.  Promptly contact Stericycle to arrange product return at 1-888-628-0728, from Monday to Friday, 8:00am to 5:00pm EDT for instructions on how to return impacted product.
Consumers with questions regarding this recall can contact Fagron Sterile Services by phone at 1-877-405-8066 M-F 8:00am – 5:00pm CDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
For more information, including links to the firm press release, visit:

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