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

Recall Number: D-0942-2017

Firm: Lantheus MI Radipharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20170712

Initiation Date: 20170518

Termination Date: 20171206

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

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