FDA-Drug2023-08-23Class III
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
Advanced Accelerator Applications USA, Inc.
Hazard
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Sold states
Distributed Nationwide in the USA
Affected count
10
Manufactured in
57 E Willow St, Millburn, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1085-2023Don't want to check this manually?
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