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
SCHAUMBURG, Ill., June 7, 2013 (GLOBE NEWSWIRE) -- Sagent Pharmaceuticals,
Inc. (Nasdaq:SGNT) 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
*Regular mail: use postage-paid, pre-addressed Form FDA3500 available at
This recall is being conducted with the knowledge of the U.S. Food and Drug
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.
CONTACT: INVESTOR CONTACT:
Jonathon Singer, Sagent
Customer Call Center
SAGENT MEDICAL AFFAIRS
(866) 625-1618, Option 3
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