Recall -- Firm Press Release
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Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Three Lots of Vecuronium Bromide for Injection, 10mg Manufactured by Mustafa Nevzat (MN Pharmaceuticals) Due to Elevated Impurity Levels
FOR IMMEDIATE RELEASE - June 7, 2013 - SCHAUMBURG, IL - Sagent Pharmaceuticals, Inc. today 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. 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.
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. 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.
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. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.
Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about Vecuronium bromide for Injection may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-7pm CST.
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 adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program either online, by regular mail or by fax.
- Online: http://www.fda.gov/MedWatch/report.htm
- Regular mail: use postage-paid, pre-addressed Form FDA3500
available at http://www.fda.gov/MedWatch/getforms.htm
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Sagent Pharmaceuticals, Inc.
Sagent Pharmaceuticals, Inc., founded in 2006, is a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectables. Sagent has created a unique global network of resources, comprising rapid development capabilities, sophisticated manufacturing and innovative drug delivery technologies, resulting in an extensive and rapidly expanding pharmaceutical product portfolio that fulfills the evolving needs of patients.