FDA Drug recall 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 Radiopharmac…
- FDA Drug
- Class III
- terminated
- Published 2017-07-12
On 2017-07-12 the FDA classified a Class III recall of Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmac… by Lantheus Mi Radipharmaceuticals, citing failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0942-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-05-18 |
| Published | 2017-07-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lantheus Mi Radipharmaceuticals |
| Distribution | PR |
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
Reason
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Identifiers
| code_info | Lot: FDG170518-01, exp 5/18/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0942-2017%22
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