June 11, 2013
Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected
AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of three lots of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent. Sagent has initiated this voluntary recall of Vecuronium Bromide for Injection to the user level due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure.
BACKGROUND: Vecuronium Bromide for Injection is a neuromuscular blocking agent indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is supplied in a glass vial. The lot numbers being recalled are: 11I30481A, 11I30721A and 11I32581A, which were distributed to hospitals, wholesalers and distributors nationwide from January 2012 through May 2012. Sagent is not aware of any adverse patient events resulting from the use of this product and is continuing its diligent investigation of the situation.
RECOMMENDATION: Sagent’s Distributor, DDN, is notifying Sagent’s distributors and customers by fax, email and certified mail and is arranging for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST.
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: www.fda.gov/MedWatch/report.htm
- 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
Read the MedWatch safety alert, including links to the Firm Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm356050.htm