Sagent Pharmaceuticals Inc recalls VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx
Recalled June 26, 2013 · FDA recall D-605-2013 · Sagent Pharmaceuticals
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. · FDA Class II
Units
831,950 vials
Sold at
Nationwide and Puerto Rico
Description
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.
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.
Manufacturer(s)
Sagent Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →