The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0942-2017·Announced 2017-07-12

Lantheus Recalls Fludeoxyglucose F 18 Injection Due to Residual Solvent

Lantheus is recalling 26 doses of Fludeoxyglucose F 18 Injection in Puerto Rico because the product failed impurity specifications for acetonitrile residual solvent.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The presence of a residual solvent failure without reported injuries aligns with a Moderate severity rating for a precautionary pharmaceutical recall.

Plain-English summary

Lantheus MI Radipharmaceuticals Inc. is recalling 26 doses of Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial. The affected product is identified by Lot FDG170518-01 with an expiration date of 5/18/2017 and NDC 11994-015-01. The recall is limited to Puerto Rico.

The recall was initiated because the product failed impurities and degradation specifications, specifically yielding an out-of-specification result for acetonitrile residual solvent. Acetonitrile is a chemical solvent that is not intended to be present in the final medication at levels exceeding established safety limits.

Healthcare providers and patients in Puerto Rico who have this specific lot of Fludeoxyglucose F 18 Injection should stop using it and contact Lantheus MI Radipharmaceuticals Inc. or their healthcare provider for instructions on how to return or dispose of the product. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

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
Manufacturer
Lantheus MI Radipharmaceuticals Inc.
Category
Drug — Radiopharmaceutical
Hazard
Affected units
26

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed in 1 state:

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