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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)

SCHAUMBURG, Ill., June 13, 2013 (GLOBE NEWSWIRE) -- Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) 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
11F23921A Jul-13 11K36761A Oct-13 12B04871A Feb-14
11G24001A Jul-13 11K37451A Oct-13 12B04921A Feb-14
11G24251A Jul-13 11K37471A Oct-13 12B06501A Feb-14
11G24471A Jul-13 11K38171A Oct-13 12B06741A Feb-14
11G24701A Jul-13 11L40161A Nov-13 12C09031A Mar-14
11G25051A Jul-13 11L40201A Nov-13 12C09041A Mar-14
11G25471A Jul-13 11L40891A Nov-13 12C09301A Mar-14
11G24341A Jul-13 11L40781A Nov-13 12C09461A Mar-14
11I30521A Sep-13 11L40851A Nov-13 12C09471A Mar-14
11I31651A Sep-13 11L40921A Nov-13 12C11641A Mar-14
11I31661A Sep-13 11L42961A Nov-13 12D12401A Apr-14
11I30481A Sep-13 11M44271A Dec-13 12D12761A Apr-14
11I30721A Sep-13 11M44371A Dec-13 12D12861A Apr-14
11I30731A Sep-13 11M44381A Dec-13 12D13061A Apr-14
11I32581A Oct-13 11M45041A Dec-13 12D13351A Apr-14
11K34241A Oct-13 11M45421A Dec-13 12D13361A Apr-14
11K34471A Oct-13 11M45641A Dec-13 12D13401A Apr-14
11K35861A Oct-13 12A02161A Jan-14 12E15981A May-14

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.

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