Advanced Accelerator Applications USA, Inc. recalls PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacture
Recalled August 23, 2023 · FDA recall D-1085-2023 · Advanced Accelerator Applications USA
Hazard
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date · FDA Class III
Units
10
Sold at
Distributed Nationwide in the USA
Description
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
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
Manufacturer(s)
Advanced Accelerator Applications USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →