Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-1085-2023

August 07, 2023

Class III

Product summary

Firm
Advanced Accelerator Applications USA, Inc.
Event
Event 92845
Status
Terminated
Classification
Class III
Quantity
10
Official record key
drug-enforcement:D-1085-2023

Official wording

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

Code information: Lot # LPS230729B-16, Exp 8/3/2023 at 10:00am, LPS230804B-16, Exp 8/9/2023 at 10:00am.

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing