Fludeoxyglucose F 18 Injection — Class III drug recall D-0942-2017
Terminated recall by Lantheus MI Radipharmaceuticals Inc., reported 2017-07-12, distributed in PR. Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
| Recall number | D-0942-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lantheus MI Radipharmaceuticals Inc., San Juan, PR, United States |
| Recall initiated | 2017-05-18 |
| Classified | 2017-07-05 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2017-12-06 |
| Distributed | PR |
| Quantity | 26 doses |
| Reason classes | specification failure |
| NDC | 11994-0015-01 |
| Lot numbers | FDG170518-01 |
| Expiration dates | 2017-05-18 |
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 for recall
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0942-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.