FDA Drug Class III — Least Serious

Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01

Hazard

Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent

Products

Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01
Brand
Lantheus MI Radipharmaceuticals Inc.
UPC
Lot: FDG170518-01, exp 5/18/2017

Units Affected

26 doses