Recall -- Firm Press Release
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Sagent Pharmaceuticals Expands a Nationwide Voluntary Recall to All Lots of Vecuronium
Bromide for Injection, 10mg Single Use Vials Manufactured by Mustafa Nevzat (MN Pharmaceuticals)
FOR IMMEDIATE RELEASE - June 13, 2013 - Sagent Pharmaceuticals, Inc. today announced the expanded voluntary nationwide recall 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 initiated a voluntary recall of Vecuronium Bromide for Injection to the user level for three lots on June 7, 2013 due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. Based on the results of additional analyses conducted since the initial recall, Sagent expanded its recall of Vecuronium Bromide for Injection, 10mg to the user level to include all lots manufactured between July 2011 and May 2012.
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 to date.
The lot numbers being recalled are (table includes the three lots recalled on June 7, 2013):
|Lot No.||Exp. Date||Lot No.||Exp. Date||Lot No.||Exp. Date|
Vecuronium bromide is used as an adjunct to general anesthesia, to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. The subject lots were distributed to hospitals, wholesalers and distributors nationwide from August 2011 through May 2013. 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, Monday-Friday, 8am-7pm CST. Healthcare workers who have medical questions about Vecuronium bromide for Injection may contact Sagent Medical Affairs (866-625-1618, Option 3) Monday-Friday, 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: www.fda.gov/medwatch/report.htm
- Regular mail: use postage-paid, pre-addressed Form FDA3500 available at 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.