drugs Class II Updated 2013-06-26

Sagent Pharmaceuticals Inc recalls VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per

Recalled Product

VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.

Hazard / Issue

CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #s: 11F23921A, 11G24001A, 11G24251A, 11G24471A, 11G24701A, 11G25051A, 11G25471A, 11G24341A, Exp 07/13; 11I30521A, 11I31651A, 11I31661A, 11I30481A, 11I30721A, 11I30731A, Exp 09/13; 11I32581A, 11K34241A, 11K34471A, 11K35861A, 11K36761A, 11K37451A, 11K37471A, 11K38171A, Exp 10/13; 11L40161A, 11L40201A, 11L40891A, 11L40781A, 11L40851A, 11L40921A, 11L42961A, Exp 11/13; 11M44271A, 11M44371A, 11M44381A, 11M45041A, 11M45421A, 11M45641A, Exp 12/13; 12A02161A, Exp 01/14; 12B04871A, 12B04921A, 12B06501A, 12B06741A, Exp 02/14; 12C09031A, 12C09041A, 12C09301A, 12C09461A, 12C09471A, 12C11641A, Exp 03/14; 12D12401A, 12D12761A, 12D12861A, 12D13061A, 12D13351A, 12D13361A, 12D13401A, Exp 04/14; 12E15981A, Exp 05/14
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