FDA-Drug2013-06-26Class II
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.
Sagent Pharmaceuticals Inc
Hazard
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.
Sold states
Nationwide and Puerto Rico
Affected count
831,950 vials
Manufactured in
1901 N Roselle Rd Ste 700, Schaumburg, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-605-2013Don't want to check this manually?
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