# FDA recall D-0007-2025

> **Advanced Accelerator Applications USA, Inc.** · Class II · drug recall initiated 2024-09-23.

## Product

Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications,  57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61

## Reason for recall

CGMP deviations

## Distribution

FL, MA, NJ, NY, PA, and VA

## Key facts

- **Recall number:** D-0007-2025
- **Recalling firm:** Advanced Accelerator Applications USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-09-23
- **Report date:** 2024-10-09

- **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-0007-2025

## Citation

> AI Analytics. FDA recall D-0007-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/D-0007-2025. Source: US FDA. Licensed CC0.

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