FDA recall D-0942-2017

Product

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

Reason for recall

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

Distribution

Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-05-18

Report date

2017-07-12

Termination date

2017-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Juan, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0942-2017