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FDAAugust 7, 2023drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

advanced accelerator applicationsadvancedadvanced accelerator

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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