Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Fludeoxyglucose F 18 Injection Recalled by Lantheus MI Radipharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications; out of specification result for...

Date: May 18, 2017
Company: Lantheus MI Radipharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Lantheus MI Radipharmaceuticals Inc. directly.

Affected Products

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

Quantity: 26 doses

Why Was This Recalled?

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

Where Was This Sold?

Puerto Rico

About Lantheus MI Radipharmaceuticals Inc.

Lantheus MI Radipharmaceuticals Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report