FDAClass IIIJuly 12, 2017

Fludeoxyglucose F 18 Injection recall: Impurity Out of Spec

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

Why was Fludeoxyglucose F 18 Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: FDG170518-01, exp 5/18/2017

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…
Recalling firm
Lantheus MI Radipharmaceuticals Inc.
Quantity
26 doses
Distribution
Puerto Rico
Recall date
July 12, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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