FDA recall D-1085-2023

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1085-2023