# FDA recall D-0942-2017

> **Lantheus MI Radipharmaceuticals Inc.** · Class III · drug recall initiated 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

## Distribution

Puerto Rico

## Key facts

- **Recall number:** D-0942-2017
- **Recalling firm:** Lantheus MI Radipharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-18
- **Report date:** 2017-07-12
- **Termination date:** 2017-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Juan, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0942-2017

## Citation

> AI Analytics. FDA recall D-0942-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0942-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*