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Succinylcholine FDA Alerts

The FDA Alerts below may be specifically about succinylcholine or relate to a group or class of drugs which include succinylcholine.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for succinylcholine

Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

ISSUE: SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. There is a potential for the products to contain microbial contamination.  See the recall notice for a full list of products.

BACKGROUND: Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue.

RECOMMENDATION: SCA Pharmaceuticals is notifying its customers via telephone, email and US mail and is arranging for return/replacement of all recalled products. Customers that have product which is being recalled, as indicated in the list above, should discontinue use immediately and return the product to SCA Pharmaceuticals.

Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059, between the hours of 8:00 am and 5:00 pm (Central Standard Time), Monday thru Friday. 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:

[10/20/2017 - Recall Notice - SCA Pharmaceuticals]


Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services: Recall - Lack of Sterility Assurance

[Posted 06/27/2017]

ISSUE: PharMEDium Services is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by PharMEDium Services were compounded using certain Hospira products. The recalled products are specific lots of Potassium Phosphate and Succinylcholine Chloride. This is a secondary recall based on a Hospira's recent recall: 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.

Refer to the recall notice for a list of the recalled lots and product photos.

BACKGROUND: These products were not distributed directly to patients or consumers, but rather to healthcare facilities (e.g. hospitals) in the United States.

RECOMMENDATION: PharMEDium Services is notifying customers of the voluntary recall by phone. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol. 

Patients and healthcare providers with questions regarding this recall can contact PharMEDium Services Clinical Pharmacist at (847) 457-2220, Monday through Friday, between 8am and 5pm Central Standard Time.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.

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:

 

[06/26/2017 - Recall Notice - PharMEDium Services]


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

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:

[06/23/2017 - Press Release - Fagron Sterile Services] 

[06/17/2017 - FDA Updates on Pfizer Drug Shortages - FDA]
 


Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance

ISSUE: Advanced Pharma, Inc. d/b/a Avella of Houston is conducting a limited, voluntary recall due to Hospira Inc.’s June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by Advanced Pharma were repackaged and/or compounded at its Houston, Texas facility using certain Hospira products. The recalled products are specific lots of Potassium Phosphate and Succinylcholine Chloride. This is a secondary recall based on a Hospira's recent recall.

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.

BACKGROUND: These products were not distributed directly to patients or consumers, but rather to healthcare facilities (e.g. hospitals).

RECOMMENDATION: Avella and Advanced Pharma are notifying customers of the voluntary recall by phone, email and overnight mail. Customers in Arizona, California, Colorado, Delaware, Georgia, Louisiana, Nebraska, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Washington that have any of the affected medications that are being recalled should immediately discontinue use and return the unused portion to Avella Specialty Pharmacy. Customers with any of the affected medications can also reference Advanced Pharma’s website for more information on the specific lot numbers affected, product images, forms and contact information: www.avella.com/AP-Hospira-recall.  For a full list of Advanced Pharma products, please visit www.avella.com/sourceb-products.

Patients and healthcare providers with questions regarding this recall can contact Avella Specialty Pharmacy recall line at (877) 292-4323, Monday through Friday, between 6am and 6pm Pacific Standard Time or via e-mail at ProductRecall@avella.com. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.

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:

[06/22/2017 - Press Release - Advanced Pharma]
[06/17/2017 - FDA updates on Pfizer drug shortages - FDA]


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