# FDA recall D-0288-2021

> **The General Hospital Corporation** · Class II · drug recall initiated 2021-02-17.

## Product

Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA  NDC 76318-334-50

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Product was distributed to one direct account.

## Key facts

- **Recall number:** D-0288-2021
- **Recalling firm:** The General Hospital Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-02-17
- **Report date:** 2021-03-03
- **Termination date:** 2021-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boston, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0288-2021

## Citation

> AI Analytics. FDA recall D-0288-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0288-2021. Source: US FDA. Licensed CC0.

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