FDAFDA · Food and drugs·Recall number D-0942-2017
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
Published July 12, 2017 · Recall initiated: May 18, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Lantheus MI Radipharmaceuticals Inc.
- Distributor
- Puerto Rico
- Lot
- Lot: FDG170518-01, exp 5/18/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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