# FDA recall D-0799-2020

> **Advanced Accelerator Applications USA, Inc.** · Class II · drug recall initiated 2020-01-10.

## Product

NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.

## Reason for recall

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

## Distribution

Nationwide in the US and Canada

## Key facts

- **Recall number:** D-0799-2020
- **Recalling firm:** Advanced Accelerator Applications USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-10
- **Report date:** 2020-01-29
- **Termination date:** 2023-07-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Millburn, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0799-2020

## Citation

> AI Analytics. FDA recall D-0799-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0799-2020. Source: US FDA. Licensed CC0.

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