Lantheus MI Radipharmaceuticals Inc. recalls Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lant…

Recall date

May 18, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0942-2017

FDA classification

Class III

Brand / firm

Lantheus MI Radipharmaceuticals Inc.

Sold / distributed

Puerto Rico

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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