# FDA recall D-0747-2022

> **Advanced Accelerator Applications USA, Inc.** · Class III · drug recall initiated 2022-03-18.

## Product

NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, 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

Subpotent Drug: low out-of-specification results for Vial 1  assay obtained during stability studies.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0747-2022
- **Recalling firm:** Advanced Accelerator Applications USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-03-18
- **Report date:** 2022-04-13
- **Termination date:** 2023-01-04

- **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-0747-2022

## Citation

> AI Analytics. FDA recall D-0747-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0747-2022. Source: US FDA. Licensed CC0.

---

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