# FDA recall D-1085-2023

> **Advanced Accelerator Applications USA, Inc.** · Class III · drug recall initiated 2023-08-07.

## Product

PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection,  9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61

## Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1085-2023
- **Recalling firm:** Advanced Accelerator Applications USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-08-07
- **Report date:** 2023-08-23
- **Termination date:** 2024-03-12

- **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-1085-2023

## Citation

> AI Analytics. FDA recall D-1085-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1085-2023. Source: US FDA. Licensed CC0.

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