Fagron Sterile Services Issues Voluntary Nationwide Recall of Succinylcholine Chloride Due to Potential For Lack of Sterility Assurance
- Company Announcement Date:
- June 23, 2017
- FDA Publish Date:
- February 08, 2018
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionLack of Sterility Assurance
- Company Name:
- Fagron Sterile Services
- Brand Name:
Brand Name(s)Fagron Sterile Services
- Product Description:
Product DescriptionSuccinylcholine Chloride 20mg/mL
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 https://www.fda.gov/Safety/Recalls/ucm563383.htm.
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. To date, Fagron Sterile Services has not received reports of any adverse events associated with this issue.
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 and is repacked by Fagron Sterile Services into 5mL doses of Succinylcholine Chloride 20mg/mL. The impacted Succinylcholine Chloride 20mg/mL lots include the following:
The impacted lots were distributed nationwide directly to hospitals and surgical clinics.
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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Fagron Sterile Services
- 1 (877) 405-8066